Cochlear Implants:Cochlear Implants:Where We’ve Been, Where We’ve Been,

Where We’re GoingWhere We’re Going

Amber M. Gardner, Ph.D., CCC-AAmber M. Gardner, Ph.D., CCC-A

University of Virginia Health SystemUniversity of Virginia Health System

Early Attempts…Early Attempts…

Alessandro Volta – early 1800s Alessandro Volta – early 1800s became the first to stimulate the became the first to stimulate the auditory system electricallyauditory system electrically Two metal rods in his ears (approx. Two metal rods in his ears (approx.

50V)50V) ““a boom within the head” followed by a a boom within the head” followed by a

sound similar to that of boiling thick sound similar to that of boiling thick soupsoup

Early Attempts…Early Attempts…

Realization made over the next 50-Realization made over the next 50-60 years that since sound is more of 60 years that since sound is more of an alternating signal, stimulating an alternating signal, stimulating with DC wasn’t going to produce an with DC wasn’t going to produce an adequate hearing sensationadequate hearing sensation

Duchenne – 1885 – used an Duchenne – 1885 – used an alternating currentalternating current ““the beating of a fly’s wings between a the beating of a fly’s wings between a

pane of glass and a curtain”pane of glass and a curtain” Improving, but not there yet…Improving, but not there yet…

Early Attempts…Early Attempts…

Brenner – 1868 – published study Brenner – 1868 – published study that revealed hearing sensation was that revealed hearing sensation was better using negative polarity. Also better using negative polarity. Also found that a reduction of unpleasant found that a reduction of unpleasant side effects could be achieved with side effects could be achieved with correct placement of the electrodescorrect placement of the electrodes

Early Attempts…Early Attempts…

1930s – thermonic valve (vacuum 1930s – thermonic valve (vacuum tube) was introduced and this tube) was introduced and this allowed greater precision in allowed greater precision in electrical stimulationelectrical stimulation

Wever & Bray (1930)– electrical Wever & Bray (1930)– electrical response recorded near the auditory response recorded near the auditory nerve of a cat was similar (freq. & nerve of a cat was similar (freq. & amplitude) to sounds to which the amplitude) to sounds to which the ear had been exposedear had been exposed

Early Attempts…Early Attempts…

Gersuni & Volokhov (1936) First to Gersuni & Volokhov (1936) First to demonstrate that with electrical demonstrate that with electrical stimulation hearing sensation still stimulation hearing sensation still remained after removal of tympanic remained after removal of tympanic membrane & ossicles – theorized the membrane & ossicles – theorized the cochlea was the site of stimulationcochlea was the site of stimulation

Early Attempts…Early Attempts…

Stevens & Jones (1939) – Listed Stevens & Jones (1939) – Listed several mechanisms that produced several mechanisms that produced hearing when the cochlea was hearing when the cochlea was stimulated electricallystimulated electrically Electrical energy could be converted Electrical energy could be converted

into sound by a direct effect on the into sound by a direct effect on the basilar membrane that would vibrate basilar membrane that would vibrate maximally at a point determined by the maximally at a point determined by the frequency – these vibrations would frequency – these vibrations would stimulate the hair cellsstimulate the hair cells

Direct stimulation of the auditory nerve Direct stimulation of the auditory nerve produced a crude hearing sensation. produced a crude hearing sensation.

Early Attempts…Early Attempts…

1940s & 1950s – Researchers began 1940s & 1950s – Researchers began to realize that if more precise to realize that if more precise hearing sensations were to be hearing sensations were to be produced stimulation of the auditory produced stimulation of the auditory nerve fibers must be more localized nerve fibers must be more localized vs. widespread current. vs. widespread current.

Early Attempts…Early Attempts…

1950 – Lundberg stimulated the 1950 – Lundberg stimulated the auditory nerve during a neurosurgical auditory nerve during a neurosurgical operation. Used a sinusoidal current - operation. Used a sinusoidal current - patient only heard noise. patient only heard noise.

1957 – Djourno & Eyries – placed a 1957 – Djourno & Eyries – placed a wire directly on the auditory nerve wire directly on the auditory nerve (cholesteatoma surgery). Initially pt. (cholesteatoma surgery). Initially pt. just heard “a roulette wheel” & “a just heard “a roulette wheel” & “a cricket” but was eventually able to cricket” but was eventually able to differentiate pitch and identify several differentiate pitch and identify several words. words.

Getting CloserGetting Closer

Doyle et al (1964) inserted an Doyle et al (1964) inserted an electrode array (4 electrodes) into electrode array (4 electrodes) into the cochlea of a deaf patientthe cochlea of a deaf patient Patient was able to repeat phrasesPatient was able to repeat phrases

Simmons (1966) inserted an Simmons (1966) inserted an electrode array into the cochlea with electrode array into the cochlea with more precision (closer to the more precision (closer to the modiolus)modiolus) Patient had ability to determine signal Patient had ability to determine signal

duration length and tonality was duration length and tonality was achievedachieved

Almost ThereAlmost There

Early 1970s - Michelson and House - Early 1970s - Michelson and House - insertion of electrode array through insertion of electrode array through scala tymani driven by implantable scala tymani driven by implantable receiver stimulators. receiver stimulators.

1972 – speech processor developed 1972 – speech processor developed to interface with the House 3M to interface with the House 3M single electrode implant & was single electrode implant & was commercially marketed. commercially marketed. Single channel devices - very poor Single channel devices - very poor

speech understanding (especially in speech understanding (especially in open set)open set)

Multi-channel Cochlear Multi-channel Cochlear ImplantImplant

Rod Saunders – First multi-channel CI patient (1978)

Courtesy: Cochlear

Increasing Channels - Increasing Channels - SpeechSpeech

Channels will increase from 1 to 2, 2 Channels will increase from 1 to 2, 2 to 4, 4 to 8 to 32 – note the to 4, 4 to 8 to 32 – note the improvement in quality. improvement in quality.

Increasing Channels - Increasing Channels - MusicMusic

First you will hear the song with 4 First you will hear the song with 4 channels, then 8, then 16, then 32 – channels, then 8, then 16, then 32 – finally you will hear the original. finally you will hear the original.

Demo

Trends in CandidacyTrends in Candidacy19851985 19901990 19981998 TodayToday

Age of Age of ImplantationImplantation

Adults age 18 Adults age 18 or olderor older

Adults & Adults & Children age 2 Children age 2 years or olderyears or older

Adults & Children Adults & Children age 18 months +age 18 months +

Adults & Children age Adults & Children age 12 months +12 months +

Onset of Onset of Hearing LossHearing Loss

PostlinguisticPostlinguistic Postlinguistic Postlinguistic Adults & Adults &

Pre/Postlinguistic Pre/Postlinguistic ChildrenChildren

Pre/Postlinguistic Pre/Postlinguistic Adults & ChildrenAdults & Children

Pre/PostlinguisticPre/Postlinguistic Adults & ChildrenAdults & Children

Degree of Degree of SNHLSNHL

ProfoundProfound ProfoundProfound Severe-to-Severe-to-Profound AdultsProfound Adults

Profound ChildrenProfound Children

Severe-to-Profound Severe-to-Profound Adults, Children > age Adults, Children > age

22Profound childrenProfound children

< 2 years old< 2 years old

Adult Speech Adult Speech ScoresScores

(open–set)(open–set)

0%0% 0%0% 40% or less 40% or less sentences in quietsentences in quiet

50% on sentences in 50% on sentences in quiet in ear to be quiet in ear to be

implanted, with 60% or implanted, with 60% or less in contralateral less in contralateral

ear or binaurallyear or binaurally

Pediatric Pediatric Speech ScoresSpeech Scores

N/AN/A 0%0% Lack of auditory Lack of auditory progress,progress,

Less than 20% Less than 20% pediatric word pediatric word

teststests

Lack of auditory Lack of auditory progress,progress,

30% or less on 30% or less on pediatric word testspediatric word tests

3 FDA Approved CI 3 FDA Approved CI ManufacturersManufacturers

Cochlear – 1985 Cochlear – 1985 Advanced Bionics – 1996Advanced Bionics – 1996 MedEl – 2001 (1994 – European MedEl – 2001 (1994 – European

release)release)

Speech Processor (1978)Speech Processor (1978)

Courtesy: Cochlear

Speech Testing (1978)Speech Testing (1978)

Courtesy: Cochlear

Cochlear – Portable Speech Cochlear – Portable Speech ProcessorProcessor

1980 – 2nd Recipient (George Watson)

Courtesy: Cochlear

Nucleus 22 Device Nucleus 22 Device

Courtesy: Cochlear

Wearable Speech Processor Wearable Speech Processor (WSP) 1982(WSP) 1982

Courtesy: Cochlear

From WSP to Mini Speech From WSP to Mini Speech Processor (MSP) 1986Processor (MSP) 1986

Courtesy: Cochlear

CI22M (Mini 22 Implant)CI22M (Mini 22 Implant)

MagnetMagnet Flexible receiver Flexible receiver

antennaantenna 19881988

Courtesy: Cochlear

MSP to SpectraMSP to Spectra

Introduced in 1988 Introduced in 1988 to go with the to go with the CI22MCI22M

Courtesy: Cochlear

CI24MCI24M

19971997 Removable Removable

MagnetMagnet Monopolar Monopolar

electrodeselectrodes Telemetry – can Telemetry – can

measure measure impedancesimpedances

Stimulation rates Stimulation rates increasedincreased

Courtesy: Cochlear

Spectra to SprintSpectra to Sprint

19971997 Increased number Increased number

of program slotsof program slots More flexibilityMore flexibility

Courtesy: Cochlear

EspritEsprit

19981998 First BTE First BTE

processor from processor from CochlearCochlear

Courtesy: Cochlear

Esprit 3GEsprit 3G

2002 (24 users)2002 (24 users) 2004 (22 users)2004 (22 users)

Courtesy: Cochlear

Freedom Freedom

2005 - New 2005 - New internal & external internal & external devicesdevices

Same processor Same processor for BTE, bodyworn for BTE, bodyworn optionsoptions

New “Smart New “Smart Sound” featuresSound” features

Courtesy: Cochlear

Courtesy: Cochlear

System 5System 5

Launched Sept. 8, Launched Sept. 8, 20092009

Internal device – Internal device – thinner, but same thinner, but same technology technology platformplatform

External – thinner, External – thinner, more water more water resistant, resistant, autophone, 2 way autophone, 2 way remote controlremote control

Courtesy: Cochlear Courtesy: Cochlear

Courtesy: Cochlear

Advanced Bionics Advanced Bionics HistoryHistory

Company started by Al Mann in Company started by Al Mann in 19931993

1996 - received FDA approval for 1996 - received FDA approval for adultsadults

1997 - received FDA approval for 1997 - received FDA approval for pediatricspediatrics

Advanced BionicsAdvanced Bionics

1.0 – 1994 (adults)1.0 – 1994 (adults) 1.2 – 1996 1.2 – 1996

(adults), 1997 (adults), 1997 (pediatrics)(pediatrics)

CII ~ 2000CII ~ 2000Courtesy: Advanced Bionics

HiRes 90kHiRes 90k

2003 2003 Titanium (vs. Titanium (vs.

ceramic) housingceramic) housing Removable magnetRemovable magnet

Courtesy: AB

AB – Body Worn AB – Body Worn ProcessorsProcessors

1.0 - 1994

1.2 - 1996

S-Series ~ 1999

PSP~ 2001

Courtesy: Advanced Bionics

AB – BTE Speech AB – BTE Speech ProcessorsProcessors

Platinum BTE

1998

CII BTE 2000

Auria & Harmony 2003 & 2006

Courtesy: Advanced Bionics

MedEl HistoryMedEl History

1975 - Hochmairs begin development of 1975 - Hochmairs begin development of cochlear implantcochlear implant

1977 - Multi-channel CI implanted in 1977 - Multi-channel CI implanted in ViennaVienna

1989 - MedEl is founded1989 - MedEl is founded 1991 - Industry first BTE speech processor 1991 - Industry first BTE speech processor

(trials)(trials) 1994 - European approval of MedEl system1994 - European approval of MedEl system 2001 - FDA approval of MedEl system2001 - FDA approval of MedEl system 2003 - FDA approval of MRI compatibility 2003 - FDA approval of MRI compatibility

(.2 Tesla)(.2 Tesla)

MedEl Internal DevicesMedEl Internal Devices

Combi 40+ Combi 40+ Introduced Introduced 19961996

Pulsar CI Pulsar CI 100 100 and Sonataand Sonata

Pulsar – Pulsar – September September 2005 (Ceramic 2005 (Ceramic Housing)Housing)

Sonata – Sonata – September September 2007 (Titanium 2007 (Titanium Housing)Housing)

Magnet fixedMagnet fixed38

Courtesy: MedEl

Tempo+ Speech Tempo+ Speech Processor (1999) Processor (1999)

Lightest BTE Lightest BTE ProcessorProcessor

Up to 9 Up to 9 ProgramsPrograms

One processor – One processor – multiple multiple wearing optionswearing options

39

Courtesy: MedEl

Opus 2 Speech Processor Opus 2 Speech Processor 20072007

Ergonomic Ergonomic switch free switch free designdesign

Wireless FMWireless FM Fine Tuner – Fine Tuner –

bilateral support, bilateral support, volume, volume, sensitivity & sensitivity & telecoil switchestelecoil switches

Courtesy: MedEl

Future DirectionsFuture Directions

Greater number of bilateral Greater number of bilateral recipientsrecipients

Hybrid/EAS cochlear implantsHybrid/EAS cochlear implants Totally implantable cochlear Totally implantable cochlear

implantsimplants

Bilateral CI Bilateral CI

Benefits Benefits Improved localizationImproved localization Improved speech in noise performanceImproved speech in noise performance

Insurance Coverage - class action Insurance Coverage - class action law-suitslaw-suits

Hybrid/EASHybrid/EAS

EAS - Electric-Acoustic StimulationEAS - Electric-Acoustic Stimulation Combination of CI & HACombination of CI & HA

High frequency information - shorter High frequency information - shorter electrode arrayelectrode array

Low frequency information - HA Low frequency information - HA (typically mild to moderate HL)(typically mild to moderate HL)

Still in clinical trials in USStill in clinical trials in US Approved in Europe (2007)Approved in Europe (2007)

All 3 companies still in US trialsAll 3 companies still in US trials43

MedEl Duet

Courtesy: MedEl

Hybrid/EASHybrid/EAS

European & trial data indicates patients European & trial data indicates patients are performing significantly better with are performing significantly better with EAS than CI alone or HA aloneEAS than CI alone or HA alone Noted especially in music & speech in noiseNoted especially in music & speech in noise

Points to considerPoints to consider Risk of damage to residual hearing acuity Risk of damage to residual hearing acuity

during original insertion of electrode arrayduring original insertion of electrode array What is the course of action if hearing acuity What is the course of action if hearing acuity

changes and HA is no longer beneficial - changes and HA is no longer beneficial - additional surgery with new/standard array? additional surgery with new/standard array?

Totally Implantable Totally Implantable Cochlear Implant Cochlear Implant

(TICI/TIKI)(TICI/TIKI) Internal ComponentsInternal Components

Rechargeable battery (lithium ion)Rechargeable battery (lithium ion) Microphone (subcutaneous)Microphone (subcutaneous) Speech processorSpeech processor

External HardwareExternal Hardware Battery rechargerBattery recharger On/OffOn/Off Volume/SensitivityVolume/Sensitivity

TIKITIKI

Totally Implantable Totally Implantable Cochlear Implant Cochlear Implant

(TICI/TIKI)(TICI/TIKI) BenefitsBenefits No external partsNo external parts

able to “hide deafness”able to “hide deafness” no cables, mics... to breakno cables, mics... to break

Able to hear 24hrs a day (in shower, Able to hear 24hrs a day (in shower, while sleeping...)while sleeping...)

Totally Implantable Totally Implantable Cochlear Implant Cochlear Implant

(TICI/TIKI)(TICI/TIKI) DisadvantagesDisadvantages

Larger internal device - more surgical Larger internal device - more surgical time/larger incision time/larger incision

Battery will have to be replaced Battery will have to be replaced (approx. 6yrs)(approx. 6yrs)

Replace only battery or entire device?Replace only battery or entire device? Hear “body noises” (breathing, Hear “body noises” (breathing,

swallowing). Some people are unable to swallowing). Some people are unable to adjust to these.adjust to these.

TIKI ResultsTIKI Results

3 patients implanted Melbourne3 patients implanted Melbourne Able to have “invisible hearing” or use Able to have “invisible hearing” or use

3G processor 3G processor Hearing acuityHearing acuity

TIKI - Mild to moderate HL (improving to TIKI - Mild to moderate HL (improving to mild HL after 6 months)mild HL after 6 months)

3G - Hearing WNL 3G - Hearing WNL Speech discrimination - CNC ListsSpeech discrimination - CNC Lists

TIKI - 33% (Improved as compared to TIKI - 33% (Improved as compared to pre-op)pre-op)

3G - 77% 3G - 77%

Thank you