auditory function screening devices - newborn

8/9/2019 Auditory Function Screening Devices - Newborn

1/25

May 2006

Product Comparison

Auditory Funct ion Screening Devices, Newborn

UMDNS informationThis Product Comparison covers the following device term and product code as listed in ECRI’s Universal Medical Device

Nomenclature System™ (UMDNS™):

Auditory Function Screening Devices, Newborn [20-167]

Table of ContentsScope of this Product Comparison ...............................................................................................................................3

Purpose..........................................................................................................................................................................3

Principles of operation..................................................................................................................................................3

Conventional versus automated..............................................................................................................................4

Reported problems........................................................................................................................................................4

Purchase considerations...............................................................................................................................................5

ECRI recommendations...........................................................................................................................................5

Other considerations................................................................................................................................................6

Stage of development....................................................................................................................................................7

Bibliography..................................................................................................................................................................7

Supplier information ....................................................................................................................................................8

About the chart specifications....................................................................................................................................10

Product Comparison Chart ........................................................................................................................................12

Comprehensive of Biomedical Engineering Site (www.dezmed.com

W

W W . D

E Z M E D

. C O M


2/25

Auditory Function Screening Devices, Newborn

Policy Statement

The Healthcare Product Comparison System (HPCS ) is published by ECRI, a nonprofit health

services research agency established in 1955. HPCS provides comprehensive information to help

healthcare professionals select and purchase diagnostic and therapeutic capital equipment more

effectively in support of improved patient care.

The information in Product Comparisons comes from a number of sources: medical and biomedical

engineering literature, correspondence and discussion with manufacturers and distributors,

specifications from product literature, and ECRI’s Problem Reporting System. While these data are

reviewed by qualified health professionals, they have not been tested by ECRI’s clinical and

engineering personnel and are largely unconfirmed. The Healthcare Product Comparison System and

ECRI are not responsible for the quality or validity of information derived from outside sources or for

any adverse consequences of acting on such information.

The appearance or listing of any item, or the use of a photograph thereof, in the Healthcare

Product Comparison System does not constitute the endorsement or approval of the product’s

quality, performance, or value, or of claims made for it by the manufacturer. The information and

photographs published in Product Comparisons appear at no charge to manufacturers.

Many of the words or model descriptions appearing in the Healthcare Product Comparison System

are proprietary names (e.g., trademarks), even though no reference to this fact may be made. The

appearance of any name without designation as proprietary should not be regarded as a

representation that is not the subject of proprietary rights.

ECRI respects and is impartial to all ethical medical device companies and practices. The

Healthcare Product Comparison System accepts no advertising and has no obligations to any

commercial interests. ECRI and its employees accept no royalties, gifts, finder’s fees, or commissions

from the medical device industry, nor do they own stock in medical device companies. Employees

engage in no private consulting work for the medical device industry.

About ECRI

ECRI (formerly the Emergency Care Research Institute) is a nonprofit health services research

agency. Its mission is to improve the safety, quality, and cost-effectiveness of healthcare. It is widely

recognized as one of the world’s leading independent organizations committed to advancing the

quality of healthcare.

ECRI’s focus is healthcare technology, healthcare risk and quality management, and healthcare

environmental management. It provides information services and technical assistance to more than

5,000 hospitals, healthcare organizations, ministries of health, government and planning agencies,

voluntary sector organizations, associations, and accrediting agencies worldwide. Its more than 30

databases, publications, information services, and technical assistance services set the standard forthe healthcare community.

ECRI’s services alert readers to technology-related hazards; disseminate the results of medical

product evaluations and technology assessments; provide expert advice on technology acquisitions,

staffing, and management; report on hazardous materials management policy and practices; and

supply authoritative information on risk control in healthcare facilities and clinical practice

guidelines and standards.

©ECRI. All Rights Reserved.

2


W

W W . D

E Z M E D

. C O M


3/25


May 2006

Auditory Funct ion Screening Devices, Newborn

Scope of this Product Comparison

This Product Comparison covers devices used to screen neonate and infant auditory responses.

Hearing aids and audiometers are excluded. For information on audiometers, see the Product

Comparison titled AUDIOMETERS; AUDIOMETRICBOOTHS.

These devices are also called: universal newborn hearing screeners (UNHSs), automated

hearing screening devices.

Purpose

Worldwide, 1 to 6 of every 1,000 infants are

born with deafness or permanent hearing loss

(Yoshinaga-Itano et al. 1998). Permanent

childhood hearing loss is the most common

defect that can be diagnosed at birth. In Europeand the United States, hospitals screen infants

within the first months of life for hearing

impairments. However, most local, state, or

national regulations require that infants be

screened within the first 48 hours of life or

before hospital discharge. UNHSs allow hearing

impairments to be detected quickly so that any

speech and language deficiencies can be

addressed with early intervention programs. If hearing impairments are not detected early in life,

social, emotional, and intellectual (e.g., speech and language acquisition, academics) development

can be affected.

Principles of operation

A UNHS consists of a main testing system with a display screen and ear tips, earmuffs, or

electrodes; the unit can be table or cart mounted. Once the ear probe(s) or electrodes are in place,

infant screening tests are performed using either auditory brainstem response (ABR) or otoacoustic

emissions (OAEs).

ABR, an electrophysiologic assessment, is used to measure the auditory system’s response to

sound. A soft click (usually 35 to 50 dB) is presented (e.g., 38 clicks/sec) to the ear(s) via earphones or

probes at a certain frequency. Electrodes are used to obtain the electrical response of the auditory

nervous system and brain. A suprathreshold acoustic stimulus causes auditory cell excitement in a

listener’s ear. This excitement causes chemicals from neurons to be released when the auditory

excitation moves from the peripheral receptor cells of the inner ear to the central auditory system.

This process produces electrical activity, which can be distinguished in an ongoing

electroencephalogram (EEG) as they are synchronized with or time locked to the acoustic stimulus.This synchronized activity can be recorded from the patient’s scalp surface. The electrical activity in

the EEG is referred to as auditory evoked potentials (AEPs), which represent the synchronization of

the neurons’ activity in response to a stimulus. ABRs are a class of AEPs that measure the integrity

of the auditory system.

Within the first 20 msec after the stimulus is delivered as clicks or short tone bursts, 5 to 7

patterned and identifiable ABR waves result. Due to the combination of ear canal acoustics and

transducer characteristics, most of the energy in the stimulus is spread over a frequency range of 1

to 5 kHz to test for hearing losses greater than 30 dB.


3


W

W W . D

E Z M E D

. C O M


4/25


ABR testing is often considered the “gold standard” due to its lower referral rates. Referral rates

are the number of referrals for additional hearing tests by an audiologist because an infant failed the

initial screening.

OAE is a screening method based on measuring the integrity of the outer hair cells in the cochlea

(inner ear) and, unlike ABR testing, does not assess auditory nerve and brainstem function. A soft

click (usually 25 dB) is presented, and a small microphone measures the acoustic response that is

returned from the baby’s ear via a probe in the ear canal. The response is analyzed to determine thefunctionality of the inner ear auditory receptor cells. OAE screeners provide valuable information on

a patient’s cochlear integrity and retrocochlear function. Therefore, this method has a wide variety of

applications beyond simple auditory screening. It has been found to be a highly reliable indicator of

hearing loss of approximately 20 to 30 dB or greater.

OAEs are sounds generated within the cochlea by the outer

hair cells. OAEs are not echoes; they are sounds generated by

active processes taking place within the cochlea of healthy ears in

response to acoustic stimulation. When a sound stimulus enters

the ear, a traveling wave is generated that propagates along the

basilar membrane within the cochlea. Inner and outer hair cells

located on the basilar membrane are excited by the resulting

displacement. A sensitive microphone measures the sound

excitation from the cochlea back to the ear canal.

OAE screening can be performed as transient-evoked

otoacoustic emissions (TEOAEs) or distortion product otoacoustic

emissions (DPOAEs). DPOAE measures responses at a single

frequency that corresponds to 2F1-F2 (i.e., normal cochlear

stimulation produces a DPOAE at a specific frequency predicted

by the formula 2F1-F2) for a given tone pair. Since a single

frequency is being used, signal averaging can be restricted to a

very narrow frequency band, which decreases the testing time.

For example, if it takes 5 to 10 seconds for each response using 4

to 5 preselected frequencies, the test would be completed in less

than one minute. Since the frequency is known before testing,

other artifacts in different frequencies can be ignored. This makes the DPOAE method less sensitiveto background noise. DPOAE measures at 8 kHz and higher. The TEOAE method is more complex

and is distributed over a wide frequency spectrum. Since the stimulus is more complex, the response

range is limited to frequencies below 4 kHz.

Conventional versus automated

Conventional units require a trained technician or audiologist to use the equipment and an

audiologist to interpret the results. The test must be performed manually, and the raw data must be

interpreted to obtain a pass/refer. Automated units use the conventional technology; however, the

equipment is fully automated and simply displays a pass or fail/refer result. No interpretation is

required, so the automated units allow various trained hospital personnel (e.g., nurses, technicians,

support staff, volunteers) to perform the screen with minimal training. Some automated units may

store raw data in case test information is requested.

Reported problems

With OAE techniques, users may experience difficulty inserting probes into the ear canal.

Improper probe fitting can increase the referral rate. Proper insertion technique is easily learned,

but the operator usually needs some instruction. Some units have alarms for improper probe

placement. Also, when the OAE technique is used too soon after birth, a false fail/refer result may

occur due to debris (e.g., vernix) in the ear canal.


4


W

W W . D

E Z M E D

. C O M


5/25


When using the automated ABR procedure, screening should be done when myogenic activity is

low. This activity is caused by muscle tension (e.g., in tense, wiggly, or restless babies). These types

of screens have artifact-rejection systems that exclude data when myogenic activity is high. High

myogenic activity will increase test time and may cause a fail/refer result.

Although the ABR technique is highly accurate, one disadvantage is that the transient stimulus

used to elicit the most robust response—namely, a very brief click or tone burst—is necessarily

broadband and therefore lacks frequency specificity.It is possible for false positives or false negatives to occur with either technology, thereby affecting

the hospital’s referral rate. However, the following can help minimize this problem:

• Ensure that the baby is quiet and calm (e.g., sleeping, just fed)• Complete a second screening before discharge for infants that do not pass the initial

screening.

• Test in a quiet area.

Purchase considerations

ECRI recommendations

The accompanying comparison chart contains ECRI’s recommendations for minimum performance

requirements for newborn auditory function screening devices. The three most important

specifications to consider are the device’s configuration (e.g., ABR, OAE), the referral rate, and

whether the system is automated.

ECRI recommends that most hospitals implementing a newborn hearing screening program use

either ABR testing or a combination of the OAE and ABR methods. ABR testing alone is effective for

all applications. To minimize the cost of testing a large number of infants, however, an effective

alternative strategy is to use OAE/ABR. The cost of disposables for OAE testing is less expensive,

but the referral rate is significantly higher. Therefore, initial screening with OAE followed by ABR

for infants failing the initial screen may reduce costs while still providing a low false-referral rate,

depending on actual (versus example or list) costs as well as other factors. This method may be

beneficial for hospitals with a high birth rate.

The primary disadvantage to this approach is the additional time delay. While ABR can be

performed earlier, OAE should be conducted at least six hours after birth. Then, if a second test isrequired, it must be scheduled and conducted afterward. With infants leaving hospitals ever earlier,

there may not always be time to complete the process. Failure to complete the protocol becomes an

additional concern for organizations with a high population of patients who tend not to follow up

with diagnostic testing because it creates more pressure for personnel responsible for ensuring

follow-up. Therefore, ECRI recommends performing the ABR test immediately following a failed

OAE test. ABR testing alone may be preferred in settings in which infants may not complete an

OAE/OAE or OAE/ABR protocol before discharge, particularly if the organization will need to expend

substantial resources on ensuring follow-up. ABR alone is also preferred if the facility is screening

within the first six hours of birth.

ABR alone should be used for a neonatal intensive care unit (NICU) because of its ability to screen

for neurologic hearing losses, which are more common in the NICU setting. Also, OAE screening may

give higher false-referral rates associated with ear infections, which are also common in the NICU

and will eventually clear up.

In most other settings, such as hospitals with only a well-baby nursery, a decision should be based

on cost analysis using actual costs. In most cases, the difference in the cost of disposables will

dominate the analysis. However, capital equipment costs and cost of personnel time should be

considered because they may influence which choice is least expensive if the costs of disposables are

similar.

Low referral rates are a good indicator of a successful newborn hearing screening program. The

American Academy of Pediatrics (AAP) endorsed the implementation of universal newborn hearing


5


W

W W . D

E Z M E D

. C O M


6/25


screening in February 1999. The AAP policy statement recommends that the referral rate to

diagnostic testing not exceed 4%.

ECRI recommends the use of automated newborn hearing screeners over manual units. With

automated technology, a trained audiologist is not needed to perform the testing. Instead, nurses or

volunteers can perform the test, which will save money on personnel costs.

Other considerations

The typical price for UNHSs ranges from $3,000 to $20,000. Before selecting the type of

equipment, a facility must determine who will be conducting the tests (audiologists, nurses, trained

technicians, or volunteers) and what test method will be employed (OAE, ABR, or both). The type of

technology selected is typically based on the birth census for a facility, the screening provider, the

training of screening personnel, the end point being measured, and the availability of an audiologist.

Facilities should consider patient load and relative costs of the different methods before deciding

on a testing protocol. Depending on patient load, ABR may be more expensive and may involve

longer test times than OAE. OAE is increasingly becoming the initial screening method because it

can be less expensive and may have a shorter test time. However, OAEs often result in a higher

referral rate due to debris in the ear canal.

Combination OAE/ABR screening devices are available. Dual or combination testing has been

found to decrease false positives and referral rates, which lowers hospital costs. However, some

audiologists prefer either the ABR or OAE method exclusively and do not wish to use dual- or

combination-testing devices.

The cost of disposables may exceed the initial acquisition cost of the screening device in one year,

depending on patient volume. Before accepting any consumables agreements, users should request

list and discounted prices for instrumentation, service, and disposable items for outright purchases,

in addition to a lease or consumables agreement. Many users select UNHSs based only on the initial

acquisition cost and do not consider the daily, long-term testing costs for consumables. Disposable

items can cost from $3,000 to $36,000/year, depending on the testing method, patient volume, and

the supplier. Users can also negotiate for the manufacturer to absorb any costs over those indicated

by the sales representative. Annual or semiannual review of patient volume can protect the facility

in the event that volume fluctuates. Prices for consumables, when negotiated, should remainunchanged for the contract duration, or at the very minimum, prices should remain unchanged for

the first three years of an agreement, with the price not to exceed the Consumer Price Index. Users

should also consider the following:

• Type of acquisition (outright purchase, lease)• Duration of contract• Patient volume• Service coverage (24 hours/day, 7 days/week; Monday through Friday, 8 a.m. to 5 p.m.)• Price increases during contract (the amount that disposables will increase in cost, cap of

inflationary prices)

• Availability of backup equipment as well as adequate consumable partsEase of use is also an important consideration. An automated system that provides a “pass or

refer” result allows nonaudiologists to complete the screening at a reduced personnel cost. The fewer

steps required to operate the system allow trained technicians to receive results more quickly and

easily. Proper earphone placement and electrode impedances during setup and continuous

monitoring during testing are important equipment checks. Obstruction in earphones (tips or muffs)

or myogenic interferences should be monitored during automatic checks to ensure that they are

within valid test ranges. Automatic self-checking procedures identify and reduce technical problems

that could increase test time. Minimization of test time is essential in accomplishing hearing

screening for newborns during the typical 48-hour hospital stay.

Equipment accuracy is necessary to ensure proper analysis of a newborn’s hearing. False-positive

and false-negative responses can be minimized with proper equipment use and calibration.


6


W

W W . D

E Z M E D

. C O M


7/25


Calibration testing and frequency vary by supplier; users should follow the operator manual.

Excessive referrals are costly and time-consuming—universal screening programs should have a

referral rate of less than 4%.

Another important consideration is speaker precalibration; confirm with the manufacturer that

the instrument was calibrated using an infant-sized (0.5 cc) coupler rather than an adult-sized (2 cc)

coupler. A signal calibrated to a larger adult ear may actually be 10 to 20 dB louder in a smaller

infant ear and therefore may miss milder hearing losses that would have been detected if theinstrument were appropriately calibrated. Using insert earphones may help to alleviate this

problem. Insert earphones accurately conduct real-ear calibration, thus ensuring that the magnitude

of the actual signal delivered to the ear is equal to the magnitude set by the user.

A UNHS database is helpful in tracking follow-up procedures and recalling patient information.

Data such as the number of infants who have passed or have been referred, test information, and

raw data from automated tests by technicians should be easily located. Patient database modules

that are built-in may eliminate the need for reentry of information. Raw data from automatic test

results should be accessible to supervising audiologists to evaluate each screening procedure; this is

important for quality assurance and accountability. The equipment should be easily upgradable with

software to accommodate new features and advances in hearing screening technology. Additionally,

the ability of the system to interface with other documentation and reporting systems in the facility

should be considered. Some hospitals require that testing information be kept for statewide agencies

and patient records.

Some equipment tests infants only. If a device can test patients of various ages, it will be more

dynamic, multifunctional, and cost-effective. A 24-hour repair or replacement schedule is critical in

UNHS programs due to patient volumes and the typical time frame in which the tests are conducted.

Users should verify that suppliers have a repair, replacement, or loaner program and should

carefully assess the response times for these options. Also, users should review licensure laws, which

may have certain requirements and/or limitations regarding screening personnel.

Some suppliers may provide user reference lists, allowing potential clients to contact user

facilities and receive feedback on integration, ease of use, and reliability.

Stage of development

Newborn hearing screening programs are well implemented in Europe, and many U.S. statescurrently have mandatory testing laws. Newborn hearing screening devices are a stable technology.

Newer models are focused on improving portability, lowering test times, and incorporating OAE and

ABR technologies into one system.

Bibliography

American Academy of Pediatrics. Task Force on Newborn and Infant Hearing. Newborn and infant

hearing loss: detection and intervention. Pediatrics 1999 Feb;102(2):527-30.

Dempesy D. Selection criteria for newborn hearing screening equipment. Hear Rev 1998 Feb;5(2):8,

10, 12, 60.

Dolphin WF. Overview of evoked response audiometric techniques: auditory screening and

diagnostics using otoacoustic emissions (OAE) and auditory evoked potentials (AEP) [online].[cited 2001 Oct 19]. Available from Internet: http://www.sonamed.com.

Gabbard SA, Northern JL, Yoshinaga-Itano C. Hearing screening in newborns under 24 hours of age.

Semin Hear 1999;20(4):291-305.

Gorga MP, Preissler K, Simmons J, et al. Some issues relevant to establishing a universal newborn

hearing screening program. J Am Acad Audiol 2001 Feb;12(2):101-12.

Knott C. Universal newborn hearing screening coming soon: “Hear’s” why. Neonatal Network 2001

Dec;20(8):25-33.


7


W

W W . D

E Z M E D

. C O M

http://www.sonamed.com/http://www.sonamed.com/http://www.sonamed.com/


8/25


National Center for Hearing Assessment and Management [Web site]. [cited 2001 Oct 19]. Logan

(UT): Utah State University. Available from Internet: http://www.infanthearing.org .

Norton SJ, Khan SB, Dolphin WF. Importance of real-ear calibration for newborn hearing screening.

Hear Rev 2000 Feb;7(2):42-4, 46.

Oudesluys-Murphy AM, van Straaten HL, Bholasingh R, et al. Neonatal hearing screening. Eur J

Pediatr 1996 Jun;155(6):429-35. Vohr BR, Oh W, Stewart E, et al. Comparison of costs and referral rates of 3 universal newborn

hearing screening protocols. J Pediatr 2001 Aug;139(2):238-44.

Yoshinaga-Itano C, Sedey AL, Coulter DK, et al. Language of early- and later-identified children

with hearing loss. Pediatrics 1998 Nov;102(5):1161-71.

Zubick H, Ringer S, Dolphin WF. Results of infant hearing screening program using a combined,

automated ABR and OAE system [online]. [cited 2001 Oct 19]. Available from Internet:

http://www.sonamed.com.

Supplier information

Bio-logic

Bio-logic Systems Corp [104756]

One Bio-logic Plaza

Mundelein, IL 60060-3708

Phone: (847) 949-5200 (800) 323-8326 Fax: (847) 949-8615

Internet: http://www.bio-logic.com

E-mail: [email protected]

Fischer-Zoth

Fischer-Zoth Diagnosesysteme GmbH, Div Natus Medical Inc [401929]

Walter-Kolbenhoff-Strasse 34

D-82110 Germering

Germany

Phone: 49 (89) 8945973 Fax: 49 (89) 89459759

Internet: http://www.fischer-zoth.de


GSI

Invacare Corp [101976]

One Invacare Way PO Box 4028

Elyria, OH 44036-2125

Phone: (440) 329-6000 (800) 333-6900 Fax: (440) 365-4558 (800) 378-4682

Internet: http://www.invacare.com


Intelligent Hearing Systems

Intelligent Hearing Systems [401964]

7356 SW 48th St

Miami, FL 33155

Phone: (305) 668-6102 (800) 447-9783 Fax: (305) 668-6103Internet: http://www.ihsys.com


Madsen

Madsen Electronics (Denmark) [139621]

Markaervej 2a Postboks 119

DK-2630 Taastrup

Denmark

Phone: 45 72111555 Fax: 45 72111348


8


W

W W . D

E Z M E D

. C O M

http://www.infanthearing.org/http://www.infanthearing.org/http://www.sonamed.com/http://www.sonamed.com/http://www.bio-logic.com/mailto:[email protected]:[email protected]://www.bio-logic.com/mailto:[email protected]://www.fischer-zoth.de/mailto:[email protected]:[email protected]://www.fischer-zoth.de/mailto:[email protected]://www.invacare.com/mailto:[email protected]:[email protected]://www.invacare.com/mailto:[email protected]://www.ihsys.com/mailto:[email protected]:[email protected]://www.ihsys.com/mailto:[email protected]:[email protected]://www.ihsys.com/mailto:[email protected]://www.invacare.com/mailto:[email protected]://www.fischer-zoth.de/mailto:[email protected]://www.bio-logic.com/http://www.sonamed.com/http://www.infanthearing.org/


9/25


Internet: http://www.madsen.com


Maico

Maico Diagnostic GmbH [236957]

Salzufer 13/14

D-10587 Berlin

GermanyPhone: 49 (30) 70714650 Fax: 49 (30) 70714699

Internet: http://www.maico-diagnostic.com


Maico Diagnostics [348943]

7625 Golden Triangle Dr

Eden Prairie, MN 55344

Phone: (952) 941-4200 (888) 941-4201 Fax: (952) 903-4200 (888) 941-4200

Internet: http://www.maico-diagnostics.com


Natus

Natus Medical Inc [108193]

1501 Industrial RdSan Carlos, CA 94070-4111

Phone: (650) 802-0400 (800) 255-3901 Fax: (650) 802-0401

Internet: http://www.natus.com


Otodynamics

Otodynamics Ltd UK [190718]

36 Beaconsfield Road

Hatfield Hertfordshire AL10 8BB

England

Phone: 44 (1707) 267540 Fax: 44 (1707) 262327

Internet: http://www.otodynamics.com


SonaMed

SonaMed Corp [362122]

1250 Main St

Waltham, MA 02451

Phone: (781) 899-6499 (888) 766-2633 Fax: (781) 899-8318

Internet: http://www.sonamed.com


Starkey

Starkey Laboratories GmbH [285021]

Rugenbarg 69

D-22848 Norderstedt

Germany

Phone: 49 (40) 528470 Fax: 49 (40) 52847222

Internet: http://www.starkey.de


Welch Allyn

Welch Allyn Inc [101850]

4341 State Street Rd PO Box 220

Skaneateles Falls, NY 13153-0220

Phone: (315) 685-4100 (800) 535-6663 Fax: (315) 685-4091

Internet: http://www.welchallyn.com

Email: [email protected]


9


W

W W . D

E Z M E D

. C O M

mailto:[email protected]:[email protected]:[email protected]://www.maico-diagnostic.com/mailto:[email protected]:[email protected]://www.maico-diagnostic.com/mailto:[email protected]://www.maico-diagnostics.com/mailto:[email protected]:[email protected]://www.maico-diagnostics.com/mailto:[email protected]://www.natus.com/mailto:[email protected]:[email protected]:[email protected]://www.otodynamics.com/mailto:[email protected]:[email protected]://www.otodynamics.com/mailto:[email protected]://www.sonamed.com/mailto:[email protected]:[email protected]://www.sonamed.com/mailto:[email protected]://www.starkey.de/mailto:[email protected]:[email protected]:[email protected]://www.welchallyn.com/mailto:[email protected]:[email protected]://www.welchallyn.com/mailto:[email protected]:[email protected]://www.welchallyn.com/mailto:[email protected]://www.starkey.de/mailto:[email protected]://www.sonamed.com/mailto:[email protected]://www.otodynamics.com/mailto:[email protected]://www.natus.com/mailto:[email protected]://www.maico-diagnostics.com/mailto:[email protected]://www.maico-diagnostic.com/mailto:[email protected]://www.madsen.com/


10/25


Welch Allyn Monitoring (New Zealand), Asia Pacific Headquarters [441593]

Level 9 Forsyth Barr House PO Box 29020

Christchurch

New Zealand

Phone: 64 (3) 3794429 Fax: 64 (3) 3792374

Internet: http://www.monitoring.welchallyn.com


Welch Allyn Monitoring GmbH [441592]

Bretonischer Ring 16

D-85630 Grasbrunn/Technopark

Germany

Phone: 49 (89) 934010 Fax: 49 (89) 9302123

Internet: http://www.monitoring.welchallyn.com


About the chart specif ications

Abbreviations:

The following abbreviations are used in the chart:

AABR — Automated auditory brainstem

response

ABR — Auditory brainstem response

ARO — After receipt of order

ASCII — American Standard Code for

Information Interchange

BS — British Standard

CD — Compact disc

CD-R — Recordable compact disc

CD-RW — Rewritable compact disc

CE mark — Conformite Europeene mark

CSA — Canadian Standards Association

dB — Decibels

dB HL — Decibels of hearing loss

dB SPL — Sound pressure level in decibels

DMS — Database management system

DP — Distortion product

DPOAE — Distortion product otoacoustic

emission

DVD — Digital versatile (or video) disc

EEC — European Economic Community

EEPROM — Electrically erasable

programmable read-only memory

EMC — Electromagnetic compatibility

EN — European Norm

EST — Eastern standard time

FDA — U.S. Food and Drug Administration

HATS — Hearing assessment tracking

system (software)

HD — Hard drive

HDD — Hard disk driveHL — Hearing loss, hearing level

HW — Hardware

IEC — International Electrotechnical

Commission

IR — Infrared

ISO — International Organization for

Standardization

LCD — Liquid crystal display

LED — Light-emitting diode

MDD — Medical Devices Directive

MOD — Magneto-optical disk

Ni-Cd — Nickel cadmium

Ni-MH — Nickel metal hydride

NIH — National Institutes of Health

OAE — Otoacoustic emission


10


W

W W . D

E Z M E D

. C O M

http://www.monitoring.welchallyn.com/mailto:[email protected]:[email protected]://www.monitoring.welchallyn.com/mailto:[email protected]://www.monitoring.welchallyn.com/mailto:[email protected]:[email protected]://www.monitoring.welchallyn.com/mailto:[email protected]:[email protected]://www.monitoring.welchallyn.com/mailto:[email protected]://www.monitoring.welchallyn.com/


11/25


PC — Personal computer SW — Software

PCMCIA — Personal Computer Memory Card

International Association

TE — Transient evoked

TEOAE — Transient-evoked otoacoustic

emissionPOVR — Point-optimized variance ratio

(algorithm used for ABaer)UL — Underwriters Laboratories, Inc.

SNR — Signal-to-noise ratioVAC — Volts of alternating current

Note: The data in the charts derive from suppliers’ specifications and have not been verified

through independent testing by ECRI or any other agency. Because test methods vary, different

products’ specifications are not always comparable. Moreover, products and specifications are subject

to frequent changes. ECRI is not responsible for the quality or validity of the information presented

or for any adverse consequences of acting on such information.

When reading the charts, keep in mind that, unless otherwise noted, the list price does not reflect

supplier discounts. And although we try to indicate which features and characteristics are standard

and which are not, some may be optional, at additional cost.

For those models whose prices were supplied to us in currencies other than U.S. dollars, we have

also listed the conversion to U.S. dollars to facilitate comparison among models. However, keep in

mind that exchange rates change often.

Need to know more?

For further information about the contents of this Product Comparison, contact the HPCS Hotline

at +1 (610) 825-6000, ext. 5265; +1 (610) 834-1275 (fax); or [email protected] (e-mail).


11


W

W W . D

E Z M E D

. C O M

http://t-4/%[email protected]://t-4/%[email protected]://t-4/%[email protected]


12/25


Product Comparison Chart

MODEL ECRI-RECOMMENDEDSPECIFICATIONS

1BIO-LOGIC BIO-LOGIC BIO-LOGIC

Newborn Auditory

Function Screeners

ABaer : AOAE ABaer Cub : AOAE Cub AuDX I

WHERE MARKETED Worldwide Worldwide WorldwideFDA CLEARANCE Yes Yes YesCE MARK (MDD) Yes Yes YesCONFIGURATION Stand-alone Portable PortableSCREENING METHOD ABR or OAE/ABR

combination ABR : DPOAE, TEOAE ABR : DPOAE, TEOAE DPOAE, TEOAE

Right only Yes Yes YesLeft only Yes Yes Yes Alternatin g No No NoSimultaneous Sequential Sequential No

AUTOMATED/MANUAL Automated Automated Automated AutomatedSTIMULUS, dB 35 : 65/55 (DP), 80 (TE) 35 : 65/55 (DP), 80 (TE) 65/55 (DP), 80 (TE)TEST TIME, AVERAGE 1-2 min : 15 sec 1-2 min : 15 sec 15 secTEST PAUSE Yes Yes YesCauses High artifact or user-

controlledHigh artifact or user-controlled

High artifact, poor probe fit

REFER RATE


13/25



MODEL ECRI-RECOMMENDEDSPECIFICATIONS

1BIO-LOGIC BIO-LOGIC BIO-LOGIC

Newborn AuditoryFunction Screeners

ABaer : AOAE ABaer Cub : AOAE Cub AuDX I

PURCHASEINFORMATIONList price, unit $12,500-14,900 with

laptop and printer 1$12,000

1$3,499 with label printer

Disposables/type $2.50/electrodes and eartips, $7.50/Ear Muffinsand electrodes

2

$2.50/electrodes and eartips, $7.50/Ear Muffinsand electrodes

2

$1/ear tip (only 1 requiredper baby)1

Warranty 1 year 1 year 1 yearSupport 24/7 with warranty or

extended program24/7 with warranty orextended program

24/7 with warranty orextended program

Training Included with purchase,user-customized

Included with purchase,user-customized


Delivery time, ARO 2-3 weeks; optional rush 2-3 weeks; optional rush 2-3 weeks; optional rushYear first sold 2000 2002 1997Number soldUSA/worldwide Not specified/>800

ABaer/AOAENot specified/~100 Not specified/>5,500 OAE

FISCAL YEAR January to December January to December January to DecemberOTHERSPECIFICATIONS

All DPOAE systems havethe option of frequencyshifting; ABaer ABR usesthe patented POVRalgorithm developed incollaboration with HouseEar Institute based on 3-year NIH study using Fsp;can be configured to usethe probe or Ear Muffinsas the transducer.

All DPOAE systems havethe option of frequencyshifting; ABaer ABR usesthe patented POVRalgorithm developed incollaboration with HouseEar Institute based on 3-year NIH study using Fsp;can be configured to usethe probe or Ear Muffinsas the transducer.

All DPOAE systems havethe option of frequencyshifting; TEOAE optionavailable.

Last Updated May 2006 May 2006 May 2006Supplier Footnotes

1These recommendationsare the opinions of ECRI'stechnology experts. ECRIassumes no liability fordecisions made based onthis data.

Model Footnotes

Data Footnotes1

Additional costs includefirst modality price of$5,500; second modalityprice of $1,000; MASTER(ASSR-Steady State) addon $12,000.2 Priceinformation current as ofJanuary 2005.

1

Introductory promotion of$10,900 (includes PocketPC and infrared labelprinter); additional costsinclude first OAE modality$5,500; second OAEmodality $1,000.2 Priceinformation current as ofJanuary 2005.

1

Price information currentas of January 2005.


13


W

W W . D

E Z M E D

. C O M


14/25



MODEL BIO-LOGIC BIO-LOGIC BIO-LOGIC FISCHER-ZOTH AuDX II AuDX Plus Scout Sport Echo-Screen TDA : Echo-

Screen TDA Plus

WHERE MARKETED Worldwide Worldwide Worldwide WorldwideFDA CLEARANCE Yes Yes Yes YesCE MARK (MDD) Yes Yes Yes YesCONFIGURATION Portable Portable Stand-alone Handheld, stand-aloneSCREENING METHOD DPOAE, TEOAE DPOAE, TEOAE DPOAE, TEOAE ABR, DPOAE, TEOAERight only Yes Yes Yes YesLeft only Yes Yes Yes Yes Alternatin g No No No YesSimultaneous No No No No

AUTOMATED/MANUAL Automated Automated Automated AutomatedSTIMULUS, dB 65/55 (DP), 80 (TE) 55/65 (DP), 80 (TE) 55/65 (DP), 80 (TE) 35, 45, 55 (ABR); 73 (TE);

55 (DP)TEST TIME, AVERAGE 15 sec 15 sec 15 sec 40 sec ABR, 30 sec

DPOAE, 20 sec TEOAETEST PAUSE Yes Yes Yes YesCauses High artifact, poor probe fit High artifact, poor probe fit High artifact, poor probe fit Automatic artifact rejection

REFER RATE 2-4% 2-4% 2-4% 0.5% ABR, 2-3% OAECALIBRATION METHOD Only by certified

distributorsOnly by certifieddistributors

Only by certifieddistributors

Sound feedback in probe

ALARMS High artifact High artifact High artifact Stimulus level impedance,probe position, artifacts

Visual/audible Visual Visual Visual Yes/yesREPORTS Printed via label printer or

PC printerPrinted via label printer orPC printer

Printed via PC printer Printout label printer,wireless link to database

DISPLAY Pass, refer, raw data Pass, refer, raw data Pass, refer, raw data Pass, refer, waveform,noise floor, stimulusmonitoring; electrodeimpedance (ABR) andphase statistics (DPOAE)

Type LCD LCD or PC screen PC screen Graphic LCD withswitchable backlight

INTERFACES Label printer Label printer Printer/HATS Label printer, IR, cableinterface to PC

STORAGE 50 tests; optional 100tests

50 tests; optional 100tests, unlimited with HD

Unlimited with hard drive Up to 250 readings

Long-term media Downloadable to PCdatabase

Optional CD/DVD Optional CD/DVD CD-R, DVD, MOD,database

POWERLine, VAC 100-240, 50/60 Hz 100-240, 50/60 Hz 100-240, 50/60 Hz NoneBattery Lithium ion Lithium ion Lithium ion Ni-MH, 6 VOperating t ime, hr 12, continuous use 12, continuous use 12, continuous use 10Rechargeable Yes Yes Yes YesRecharge tim e, hr 5 5 5 2

Low-battery alarm Yes Yes Yes Yes

This is the first of twopages covering the abovemodel(s). Thesespecifications continueonto the next page.


14


W

W W . D

E Z M E D

. C O M


15/25



MODEL BIO-LOGIC BIO-LOGIC BIO-LOGIC FISCHER-ZOTH AuDX II AuDX Plus Scout Sport Echo-Screen TDA : Echo-

Screen TDA Plus

PURCHASEINFORMATIONList price, unit $6,500 without label

printer, $7,000 with labelprinter

$9,000-11,000 with laptopand printer

$7,500-10,000 with laptopand printer

$8,500 TEOAE/ABRhandheld

Disposables/type $1/ear tip (only 1 requiredper baby)1



$0.50/ear tip, $1.95/ABRelectrode set

Warranty 1 year 1 year 1 year 2 yearsSupport 24/7 with warranty or

extended program24/7 with warranty orextended program

24/7 with warranty orextended program

24/7 country dependent,1-day repair

Training Included with purchase,user-customized



Half day on-site

Delivery time, ARO 2-3 weeks; optional rush 2-3 weeks; optional rush 2-3 weeks; optional rush 4-6 weeksYear first sold 1997 1997 1996 2001Number soldUSA/worldwide Not specified/>5,500 OAE Not specified/>4,000 total

OAENot specified/>4,000 totalOAE

0/50

FISCAL YEAR January to December January to December January to December January to DecemberOTHERSPECIFICATIONS

All DPOAE systems haveoptional frequencyshifting; TEOAE optionavailable.

All DPOAE systems haveoptional frequencyshifting; SOAE(spontaneouscapabilities); TEOAEoption available.

All DPOAE systems haveoptional frequencyshifting; SOAE(spontaneouscapabilities); TEOAEoption available.

Link to database (SIMSOz, HiTrak, MS Access);label printer; standardTEOAE/DPOAE probeused for ABR. Meetsrequirements of EN 46001(1996), 60601-1 + A1 + A2, and 60601-1-2 (1993);EN ISO 9001 (1994); andEuropean CouncilDirective 93/42/EEC.

Last Updated May 2006 May 2006 May 2006 January 2005Supplier Footnotes

Model Footnotes

Data Footnotes1Price information current

as of January 2005.

1Price information current

as of January 2005.

1Price information current

as of January 2005.


15


W

W W . D

E Z M E D

. C O M


16/25



MODEL FISCHER-ZOTH GSI GSI INTELLIGENT HEARINGSYSTEMS

Echo-Screen TE : Echo-Screen TE Plus

AUDIOscreener GSI-70 Single patient :GSI-70 Multipatient

SmartDPOAE :SmartTROAE

WHERE MARKETED Worldwide Worldwide Worldwide WorldwideFDA CLEARANCE Yes Yes Yes YesCE MARK (MDD) Yes Yes Yes NoCONFIGURATION Handheld, stand-alone Stand-alone, portable,

handheldStand-alone, portable,handheld

Portable

SCREENING METHOD TEOAE ABR, DPOAE, TEOAE DPOAE DPOAE : TROAE;optional automated ABRand ASSR integration

Right only Yes Yes Yes YesLeft only Yes Yes Yes Yes Alternatin g Yes No No NoSimultaneous No No No No

AUTOMATED/MANUAL Automated Both Automated BothSTIMULUS, dB 73 dBA impulse 35 dB nHL default (0-100

dB SPL programmable) ABR and 65/55 dB SPLdefault (45-70 dB SPLprogrammable) OAE

65/55 dB SPL 0-100 dB SPL, user-definable TROAE; 0-70dB SPL, user-definableDPOAE

TEST TIME, AVERAGE 20 sec 1 min/ear OAE, 1.5min/ear ABR

1 min/ear 30-60 sec, depends ontest parameters

TEST PAUSE Yes Yes Yes YesCauses Automatic artifact rejection User intervention, noisy

environmentNo seal, noisyenvironment

User request, artifacts

REFER RATE 2-3% 2% 4% By user protocolCALIBRATION METHOD Sound pressure level 73

±3 dBReal ear, coupler Real ear, coupler Automated and manual for

in ear ALARMS Probe error, battery

check, artifact rateProbe-fit error, impedanceout of bounds, low battery

Low battery Noise, probe fit

Visual/audible Yes/no Yes/no Yes/no Yes/noREPORTS Printout label printer, PC

downloadPrinted, plain paper; fullsheet; short- and full-detailforms with AUDIOtrac and AUDIOscreener

Internal printer for instantresults, download to DMSsoftware to print

Letters and data, user-definable templates

DISPLAY Pass, refer, stimulusstability, artifact rate

Pass, refer, full graphics Pass, refer, noise, abort Pass, refer, raw data :Statistics, raw data

Type LCD LED LCD/backlight :Touchscreen

LCD

INTERFACES Label printer, line printer,RS232 interface

IrDA IrDA, RS232 Any Windows-compatibleprinter

STORAGE Up to 4 readings : Up to120 readings

300 patient records; eachpatient record contains upto 3 OAEs/ear and up to 3 ABRs/ear; OAE test has 5frequencies, and ABR testhas 8 stimuli; all stored innonvolatile flash memory

350 test results,multipatient

Varies by hard drive

Long-term media Printout, any PC backupmedium

With PC, hard disk, CD,tape backup

With PC, hard disk, CD,tape

Optional CD-RW

POWERLine, VAC None 100-240, 50/60 Hz 90-260, 50/60 Hz 100-240, 50/60 HzBattery Ni-MH, 6 V Ni-MH Ni-Cd NoOperating t ime, hr 10 16 continuous, 24 average 90 tests/90 min NARechargeable Yes Yes Yes NARecharge tim e, hr 2 2 8 NA

Low-battery alarm Yes Yes Yes NA



16


W

W W . D

E Z M E D

. C O M


17/25



MODEL FISCHER-ZOTH GSI GSI INTELLIGENT HEARINGSYSTEMS

Echo-Screen TE : Echo-Screen TE Plus

AUDIOscreener GSI-70 Single patient :GSI-70 Multipatient

SmartDPOAE :SmartTROAE

PURCHASEINFORMATIONList price, unit $3,500 basic $16,500 $3,500 : $5,500 $5,692 USB kit with 10D

probe, $18,181SmartScreener/SmartOAESmartEP-ASSRcombination

Disposables/type $0.50/ear tip $9/comfort cup set,$3.50/probe tip

Not specified $0.97/pediatric 10D OAEear tip

Warranty 2 years 1 year 1 year 1 year; optionalextensions

Support 24/7 country dependent,1-day repair

24/7 Included with purchase Local distributors,included 9-5 EST M-F

Training 2 hr on-site Yes Included with purchase Half day on-site by localdistributor

Delivery time, ARO 3-5 weeks 1 week 5 days 4-6 weeks; rush optionavailable

Year first sold 1995 2002 1999 1997 : 2003Number soldUSA/worldwide 800/3,000 Not specified Not specified/2,000 Not specified

FISCAL YEAR January to December January to December January to December January to DecemberOTHERSPECIFICATIONS

Link to database (SIMSOz, HiTrak, MS Access)via PC-based "Echo-Link"software; label or lineprinter. Meetsrequirements of EN 46001(1996), 60601-1 + A1 + A2, and 60601-1-2 (1993);EN ISO 9001 (1994); andEuropean CouncilDirective 93/42/EEC.

Data can be read by staffaudiologist or e-mailed toconsulting audiologist;wireless data transmissionto and from desktopcomputer (up to 300patient records); testsnewborns to elderlypatients.

Multipatient version allowsdownloading of your ownprotocol and normativedata; up to 6 frequenciestested; data can beincorporated withNCHAM, Oz systems, andthe GSI 60 diagnosticDPOAE systemsdatabase.

Can be combined withSmartEP, SmartEP- ASSR, SmartScreener,and SmartAudiometer;integrated calibration;network capability; reportgeneration; databasemanagement andscheduling features; user-defined passing criteriaand normative datadisplays; online help menuand manual; free softwareupgrades; toll-freecustomer support forsystem's life; USB

Windows interface;spontaneous OAEcapability included;optional USB standardmodel; USB standardmodel can be upgraded toinclude high-frequencyoption, OAE suppression,IVRA, and 4 EP channels.

Last Updated January 2005. October 2003 October 2003 May 2006Supplier Footnotes

Model Footnotes

Data Footnotes


17


W

W W . D

E Z M E D

. C O M


18/25



MODEL INTELLIGENT HEARINGSYSTEMS

INTELLIGENT HEARINGSYSTEMS

MADSEN MAICO

SmartEP-ASSR SmartScreener AccuScreen Ero Scan Combo : EroScan Screener : Ero Scan

StandardWHERE MARKETED Worldwide Worldwide Worldwide WorldwideFDA CLEARANCE Yes Yes Yes YesCE MARK (MDD) No No Yes YesCONFIGURATION Portable Portable Portable PortableSCREENING METHOD ASSR; optional automatic

ABR/OAE integration ABR; optional automaticOAE/ASSR integration

DPOAE, TEOAE, AABR DPOAE, TEOAE

Right only Yes Yes Yes YesLeft only Yes Yes Yes Yes Alternatin g No No Yes NoSimultaneous Yes No No No

AUTOMATED/MANUAL Both Automated Automated BothSTIMULUS, dB 0-125 dB SPL, user-

definable0-100 dB HL, user-definable

70-85 SPL 40-70 (DP), 83 (TE)

TEST TIME, AVERAGE 12-25 min, depends ontest parameters

10-15 min, depends ontest parameters

10-15 sec


19/25



MODEL INTELLIGENT HEARINGSYSTEMS

INTELLIGENT HEARINGSYSTEMS

MADSEN MAICO

SmartEP-ASSR SmartScreener AccuScreen Ero Scan Combo : EroScan Screener : Ero Scan

StandardPURCHASEINFORMATIONList price, unit $15,750 USB Jr. kit, 2-

channel SmartEP-ASSR,$18,181SmartScreener/SmartEP- ASSR/SmartOAEcombination

$10,915 USB Jr. kit,1channel SmartScreener;$18,181 2-channelSmartScreener/SmartEP- ASSR/SmartOAEcombination

$3,995-12,995 dependson configuration

€4,000 (US$3,453); €7,000 (US$6,044)

Disposables/type $2.33-10.11/disposablesand nondisposables

$2.33-10.11/disposablesand nondisposables

$0.76/ear tip $0.12/ear tip

Warranty 1 year; optionalextensions

1 year; optionalextensions

1 year 2 years

Support Local distributors,included 9-5 EST M-F

Local distributors,included 9-5 EST M-F

Through local distributor Yes

Training Half day on-site by localdistributor

Half day on-site by localdistributor

Not specified Video, seminar

Delivery time, ARO 4-6 weeks; rush optionavailable

4-6 weeks; rush optionavailable

1 week 2-3 weeks

Year first sold 2003 1993 2001 2000Number soldUSA/worldwide Not specified Not specified 500/2,000 Not specified

FISCAL YEAR January to December January to December Not specified Not specifiedOTHERSPECIFICATIONS

Can be combined withSmartEP (full diagnosticEP system,SmartScreener,SmartAudiometer, andSmartOAE); optional USBstandard model; USBstandard model can beupgraded to include high-frequency diagnostic EPand OAE option, TEOAESuppression, IVRA, and 4EP channels; integratedcalibration; network

capability; reportgeneration; databasemanagement andscheduling features; user-defined passing criteriaand normative datadisplays; online helpmenu, manual; freesoftware upgrades; toll-free customer support forsystem's life; USBWindows interface.

USB Windows interface;can be combined withSmartEP, SmartOAE,SmartAudiometer andSmartEP-ASSR;integrated calibration;network capability; reportgeneration; load data intoSmartEP to plot againstnormative data; built-indemonstrations; databasemanagement andscheduling features;online help menu and

manual; free softwareupgrades; toll-freecustomer support forsystem's life; USBWindows interface;optional autopeaklabeling; optional USBstandard model; USBstandard model can beupgraded to include high-frequency option, TROAEsuppression, IVRA, and 4EP channels.

Label printer; 2 probes; 2batteries; carrying case.

External and built-in probeavailable; printer availablewith graphic printout;delivers frequency-specificinformation; PC softwareincluding patientdatabase; test protocolchanges can be madethrough OAE unit(software and PC notrequired); patented posthoc statistical analysisthat rejects noise-contaminated samples,

allowing TEOAEmeasurements in under20 sec in speech-babblelevels from 40-70 dB SPL.

Last Updated May 2006 May 2006 January 20051

May 2006Supplier Footnotes

Model Footnotes

Data Footnotes1Declined to participate;model is currentlymarketed.


19


W

W W . D

E Z M E D

. C O M


20/25



MODEL MAICO NATUS NATUS NATUSMB 11 ALGO 3 ALGO 3i Echo-Screen

WHERE MARKETED Worldwide Worldwide Worldwide WorldwideFDA CLEARANCE Yes Yes Yes YesCE MARK (MDD) Yes Yes Yes YesCONFIGURATION Portable Laptop computer, label

printer, cartHandheld device, labelprinter, case

Handheld device, labelprinter, case

SCREENING METHOD AABR, ABR AABR AABR TEOAE, DPOAE, AABR;6 configurations

Right only Yes Yes Yes YesLeft only Yes Yes Yes Yes Alternatin g No Sequentially Sequentially SequentiallySimultaneous No Yes Yes No

AUTOMATED/MANUAL Both Automated Automated AutomatedSTIMULUS, dB 40 (step simultaneously in

6 levels); ABR standard35, 40 35, 40 35, 45, 55 dB nHL

TEST TIME, AVERAGE 1 min 4-7 min, as low as 30 sec 4-7 min, as low as 30 sec 4-7 min, as low as 30 secTEST PAUSE Not specified Not specified Not specified Not specifiedCauses Not specified Not specified Not specified Not specified

REFER RATE


21/25



MODEL MAICO NATUS NATUS NATUSMB 11 ALGO 3 ALGO 3i Echo-Screen

PURCHASEINFORMATIONList price, unit €7,500 (US$6,479) Not specified Not specified Not specifiedDisposables/type Not specified/electrodes Not specified Not specified Not specified

Warranty 2 years Not specified Not specified Not specifiedSupport Not specified Technical and customer

supportTechnical and customersupport

Technical and customersupport

Training Not specified Training programs onproduct equipment andsupplies, clinicalconsultation, andeducational materials

Training programs onproduct equipment andsupplies, clinicalconsultation, andeducational materials

Training programs onproduct equipment andsupplies, clinicalconsultation, andeducational materials

Delivery time, ARO 2-3 weeks Not specified Not specified Not specifiedYear first sold 2001 Not specified Not specified Not specifiedNumber soldUSA/worldwide Not specified Not specified Not specified Not specified

FISCAL YEAR Not specified January to December January to December January to DecemberOTHERSPECIFICATIONS

Objective determination ofhearing threshold in 2 min;no glueable electrodes;only some electrodeconductivity gel isrequired; patient databaseincluded in PC software.

Compatible with variousdata managementsystems. Meets the American Academy ofPediatrics (AAP) guidelinefor a


22/25



MODEL OTODYNAMICS OTODYNAMICS SONAMED STARKEYECHOCHECK ECHOPORT ILO288 USB Clarity ABR Screener DP2000 (DPOAE) : T2001

(TEOAE)

WHERE MARKETED Worldwide Worldwide USA WorldwideFDA CLEARANCE Yes Yes Yes YesCE MARK (MDD) Yes Yes Not specified YesCONFIGURATION Portable, handheld Portable with USB

connection to PCNot specified Stand-alone, portable;

operates usding a desktopor laptop computer

SCREENING METHOD TEOAE DPOAE, TEOAE ABR, DPOAE DPOAE, TEOAERight only Yes Yes Yes Not specifiedLeft only Yes Yes Yes Not specified Alternatin g No No No Not specifiedSimultaneous No No No Not specified

AUTOMATED/MANUAL Automated Both Automated BothSTIMULUS, dB 84 dB SPL 0-95 dB SPL 30-45 dB nHL (ABR), 65-

55 dB SPL (DPOAE)NA

TEST TIME, AVERAGE 10 sec 10 sec Varies; 2-10 min average


23/25



MODEL OTODYNAMICS OTODYNAMICS SONAMED STARKEYECHOCHECK ECHOPORT ILO288 USB Clarity ABR Screener DP2000 (DPOAE) : T2001

(TEOAE)

PURCHASEINFORMATIONList price, unit Not specified Not specified $25,000 $8,000; $8,950 for

combinationDisposables/type Not specified Not specified Ear tips, electrodes $0.85/ear tips

Warranty 1 year 1 year 1 year, extended contractavailable

1 year, limited; 2 years forsoftware updates

Support Local dealer Local dealer Phone Included with purchaseTraining Not specified Not specified First in-service included 1 day on-siteDelivery time, ARO 2 weeks 2 weeks 4-8 weeks 1 weekYear first sold Not specified 2002 1997 1994Number soldUSA/worldwide Not specified Not specified Not specified Not specified

FISCAL YEAR Not specified Not specified Not specified Not specifiedOTHERSPECIFICATIONS

Meets requirements of BS5724-1, CSA 22.2 No.601-1, EMC, EN 60601-1,IEC 601, and UL 2601.

Meets requirements ofCE, CSA 22.2 No. 601-1,EMC, EN 60601-1, andUL 2601.

None specified. Lightweight; Windowsbased; 2 clicks of themouse to administer testand observe pass/referresult; both systemsinterface with differentinformation managementsystems, including SIMSOz, HiTrak, and Microsoft Access.

Last Updated May 2006 May 2006 May 2006 January 2005Supplier Footnotes

Model Footnotes

Data Footnotes


23


W

W W . D

E Z M E D

. C O M


24/25



MODEL WELCH ALLYNOAE Hearing Screener

WHERE MARKETED USAFDA CLEARANCE YesCE MARK (MDD) NoCONFIGURATION PortableSCREENING METHOD DPOAERight only YesLeft only Yes Alternatin g NoSimultaneous No

AUTOMATED/MANUAL AutomatedSTIMULUS, dB 55/65 (DP)TEST TIME, AVERAGE 10 secTEST PAUSE YesCauses High artifact, poor probe fit

REFER RATE 2-4%CALIBRATION METHOD Only by certified

distributors ALARMS High artifact

Visual/audible VisualREPORTS Label via label printer

DISPLAY Pass, refer, raw dataType LCD

INTERFACES Label printerSTORAGE 10 testsLong-term media NA

POWERLine, VAC 100-240, 50/60 HzBattery Lithium IonOperating t ime, hr 12, continuous useRechargeable YesRecharge tim e, hr 5

Low-battery alarm Yes



24


W

W W . D

E Z M E D

. C O M


25/25



MODEL WELCH ALLYNOAE Hearing Screener

PURCHASEINFORMATIONList price, unit $3,995 with label printerDisposables/type $1/ear tip

Warranty 1 yearSupport 24/7 with warranty or

extended programTraining Included with purchaseDelivery time, ARO 1 week; optional rushYear first sold 2006Number soldUSA/worldwide Not specified

FISCAL YEAR January to DecemberOTHERSPECIFICATIONS

All DPOAE systems havethe option of frequencyshifting.

Last Updated May 2006Supplier Footnotes

Model Footnotes

Data Footnotes


W

W W . D

E Z M E D

. C O M

auditory function screening devices - newborn

Documents