lyric2 patient selection en lrc - … · tragus with other hand to straighten ... •tube and...

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Patient Selection

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Patient Selection

Lyric Candidacy• Patients are evaluated for Lyric candidacy using four primary

criteria:

– Fitting Range

– Lifestyle

– Ear Geometry / Anatomical Features

– Medical History and Condition

Candidacy - Fitting Range

Be cautious of steeply sloping losses

Candidacy - Lifestyle

• Lyric use is not recommended for patients who engage in the

following:

– Underwater swimming (complete submersion of the head)

– Regular scuba diving

– Regular sky diving

– Routine MRIs

Candidacy - Ear Geometry / Anatomical Features

• Visualization of the entire ear canal, especially to note

challenging canal shapes or anatomical features, is vital for

ensuring a comfortable fit

– Noteworthy Canal Shapes:

• Hourglass shape

• Anterior or Anterior/Posterior bulge

• V shaped canal at any location

• Substantial step up, or shelf in canal

Candidacy - Medical Clearance

• Prior to Lyric use, medical clearance is recommended for

patients with the following conditions:

– Prescription anticoagulation therapy

– Diabetes

– Compromised immune system (including, but not limited to):

• Chemotherapy within the last 6 months

• HIV

• Sickle Cell Disease

• Lupus

• Advanced Rheumatoid Arthritis

• Organ transplant

Middle Ear Conditions

– Chronic or acute drainage

– TM Perforation

– PE Tubes

– Cholesteatoma

Skin Conditions

– Chronic external otitis

– Keratosis obturans

Other Conditions

– Radiation to the head or

neck ever

– Cognitive ability

(insufficient to understand

device use)

– Chronic ear pain

Candidacy - Medical Contraindications

Lyric use is contraindicated for patients with the following

conditions:

Contraindicated Placements

• Placing Lyric in a contraindicated canal will likely result in:

– Trial cancellation

– Discomfort/pain for the patient

– Ear canal concerns:

• Hematoma

• Laceration

• Abrasion

• Moisture accumulation

Ear Canal Hematomas and Cerumen

Ear Canal Laceration

Hematoma on the TM

Moisture Accumulation

Equipment

• Before sizing or fitting Lyric, it is important to obtain and

become comfortable using the appropriate equipment

– Placement of Lyric deep in the canal can be difficult to visualize

without proper equipment

• Magnification and illumination: microscope or head loupe

• Ergonomics: patient chair, provider stool

• Tools: Lyric fitting kit

– Lyric recommended equipment is also very useful for cerumen

management

Magnification and canal illumination are

paramount to your Lyric success!

9/25/2012 Page 15

Otoscopy

Objectives:

•Visualize complete ear canal to develop « flight path » for sizer and

device insertion

•Ensure clean and healthy skin throughout the whole canal

•Detect any abnormalities in the ear canal regarding skin condition,

canal shape and the ear drum to rule out contraindications

•Detect any abnormalities before refitting an ear canal

If any abnormalities are detected, refer to an ENT for

clarification

9/25/2012 Page 16

Otoscopy

Approach:

Work your way in starting at the

concha through the cartilagenous and

bony part to the eardrum

9/25/2012 Page 17

Otoscopy

What are we looking for?

A clean, healthy and straight canal without significant changes in

shape and diameter

However, for most ears the reality looks different…

9/25/2012 Page 18

Otoscopy

Eardrum

Most canals are rising and / or…

…have an S-shape

Source: Jean Courtois: Cerumen und Fremdkörper im Gehörgang

9/25/2012 Page 19

Otoscopy

Tilt head to compensate for rise, turn head to compensate for bend

Move the head of the patient to aid with otoscopy:

9/25/2012 Page 20

Otoscopy

For a first overview, start otoscopy

without speculum, …

... it focuses the view to a small area.

9/25/2012 Page 21

pull ear backwards and up and move

tragus with other hand to straighten

ear canal

Otoscopy

pull ear backwards and up and

hold speculum with index finger

and thumb of other hand

Watch out for fingernails and always brace with the hand holding the speculum!

Without speculum… With speculum…

9/25/2012 Page 22

Otoscopy

Start at concha and locate

posterior meatus

…before checking the

cartilagenous portion.

9/25/2012 Page 23

Otoscopy

The bony portion is most critical for fitting success!

Cerumen that needs to be removed

Bulge at front, round shape at the back (common shape)

+ cerumen

+ small exostoses

Bulge on both sides leading to strong v-shape

Exostoses

9/25/2012 Page 24

Otoscopy

Finally: the ear drum

Cerumen that needs to be removed

With the help of head movements,

the whole drum can be visualized

Contraindicated ear with perforation

and finally the ear drum

9/25/2012 Page 25

To fit or not to fit?

9/25/2012 Page 26

To fit or not to fit?

9/25/2012 Page 27

To fit or not to fit?

9/25/2012 Page 28

To fit or not to fit?

9/25/2012 Page 29

To fit or not to fit?

9/25/2012 Page 30

To fit or not to fit?

9/25/2012 Page 31

These ears have worn

Lyric for 6 years!

2005

2011

Lyric Hall of Fame

Inspect Ear Canal Prior to Sizing and Placement

Ear must be healthy and completely free of cerumen and debris

• Carefully inspect entire ear canal for candidacy and trajectory; look at:

– First bend in canal

– Bony cartilaginous juncture

– Medial seal location (4 mm from TM)

– TM

• Will be working blind during insertion, it is important to visualize the

canal (know your flight plan)

Sizing Objectives

• Determine if the ear canal is the appropriate size and length

to accommodate Lyric

– Size of Seals

– Maximum Depth of Insertion

Sizing & Placement Reference Point

• Use the posterior

meatus as a reference

for sizing and placing

Lyric

Canal and Device Dimensions

Lateral Seal Medial Seal

Posterior Meatus Lyric2 Device Tympanic Membrane

4 mm 12 mm 4 mm

20 mm

Lyric2 Sizing System

Length Sizer

Handle

Flexible Tip Body of Sizer

Device Sizers

Removal loops

Insertion handle

Pressure vent

Superior indicator

Device Size Sizer color

XS

S

M

L

XL

• Replicas of the actual device

– Have the same look and feel of actual

devices

– Represent device “drivability”

– Require less guesswork in size decision

• Not ear specific

• Vented through the core

• Seal sizes vary from XS-XL

– The core is the same size throughout

Lubrication

• 100% glycerin or sterile/distilled water is

recommended as lubrication during

device sizing and device insertion

• Neither option leaves a residue

• Apply with a cotton swab lightly to the canal wall

and medial seal of sizer or device

– Apply gently

– Do not over apply

– Avoid plugging the microphone or receiver with

excessive lubricant

• Re-apply as necessary

Insertion Tool

Lyric2 Insertion Tool

• Spring loaded

• Three rings allow for natural finger

placement

– Ergonomic design

• Allows for user control when

inserting and removing

– Tension can be increased or decreased

– Allows for flexible device “driving”

• Device stays on tool

– Even with fingers relaxed or no tension

on tool, device remains in place

Parts of Insertion Tool

Depth Scale

Sliding Depth Ring

Loading Notch

Removal Notch

Tip

Fixed Finger Ring

Moving Tension Ring

Fixed Thumb Ring

Depth Collar

Lyric fitting kit

Loading the insertion tool

•To load a device or sizer, start by completely squeezing

the moving tension ring toward the thumb ring

•This extends the loading hook forward to the tip

Loading Devices/Sizers on Insertion Tool

•Position the device face down and just

above the insertion tool•Dot is towards you

•Tube and removal loops toward the floor

•Squeeze the finger rings while threading

removal loops into the loading notch

•Once the loops are in place slowly release

your finger grip while placing the device on

the tip of the insertion tool

Remember finger rings

control tension

Determining Lyric2 size

• For new patients, start with S Device sizer (Green core)– For existing Lyric patients start with the medial seal size

• Gently lubricate the canal wall using water or glycerin on a cotton swab

• Load the S sizer on the insertion tool using the black dot as superior indicator

• The insertion tool is designed to allow variable tension (by extending or

retracting the moving tension ring)– For most ears, varied tension will be required to maintain the appropriate device angle

when navigating the bends of the canal

– Once device is past posterior meatus, tension should be relieved to prevent undue

pressure being applied to canal walls

• Release sizer and check seal for gaps or folds

• If there are folds in the seal, the sizer is too big and an XS should be tried

• If gaps are present between the seal and canal wall, the sizer is too small and the

M or eventually L should be tried

• Insert multiple sizers for comparison to determine best fit

Device activation prior to insertion

• Wash hands thoroughly

• Remove the device from its packaging

• Send Target settings to device via programming wand (one-way

transmission)

• Perform listening check with device connected to a sterilized stethoclip

bell

Inserting Lyric2 device

• If warranted, gently re-lubricate the canal wall

• Load the device on the insertion tool using the black dot as superior indicator

• As with sizers:– Be mindful of the need for variable tension as you steer through the ear canal

– Varied tension will be required to maintain the appropriate device angle when navigating

the bends of the canal

– Once past the posterior meatus, tension should be relieved to prevent undue pressure

being applied to canal walls

• Completely squeeze moving tension ring

• Release the device and check for gaps/folds

• Verify comfort

Insertion tips

Tricks of the Trade• Squeeze = Release

– The insertion tool releases tension when squeezed!

• Widen = Tighten

• Device is no longer jointed

– Line up the tool in whatever direction you want to move the device

• Still need to develop that flight plan!

• Look for 12 mm of real estate to “park” this device

• Leave device “ON” while inserting

– Listen for feedback to subside

– Tool does not allow easy repositioning

• May need to use Lyric forceps to make positional changes once device is

in place

– Must remove device for gross device placement changes

Practitioner device/sizer removal

• Enter the canal with the removal

notch up

• “Scoop” the removal lines into

the removal notch

• Once engaged, gently “wiggle”

the device outward

Removal tips

Removal can be more difficult on deeper insertions

and narrower ear canals• Removal lines can fall to canal floor over time

– Be careful not to abrade canal walls while finding removal loops

• You can't always remove the device using the removal loops or insertion tool

– Use blunt nose tweezers or forceps to grab the removal loops

– Device does have a handle inside the protection tube

– Pulling on seals or the protection tube will often leave them compromised

• Gently lift up as you remove from canal to ensure device retention in removal

notch

– Be careful not to let tip of insertion tool fall once out of the canal

Patient device removal

Use circular motion to

engage removal loops on

device, once engaged,

gently pull

Once patient removes

device, it cannot be

reused

Patient practice: Device removal

Sizers are replicas of devices, equipped with

removal loops. Patients can “practice” self -

removal in your office

Care and use in the office:

• Store devices away from electromagnetic interference (e.g. microwave, x-ray machine, autoclave)

• Do not use if foil package seal has been compromised

• Do not use if temperature indicator has changed color

• Handle device hygienically

Infection Control

Clean insertion tool and

specula by:

– Autoclave

• Note that the plastic

components of the tool

may discolor but

functionality will remain

intact

– Cold sterilization

• Complete submersion in

cold sterilant in designated

tray overnight

• Rinse and pat or air dry

9/25/2012

Patient Selection