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Kristin M. Avitabile, MS, CCC-AClinical Manager, Southeastern U.S.

MED-EL Corporation

Vibrant Soundbridge Implantable Hearing System


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Hearing Technology

Hearing Aids

Mild to severe HL Problems with feedback

and cosmetics

Middle Ear Implants

Moderate to severe HL

For people who are unableto achieve adequatebenefit or medically unable

to tolerate HAs Cochlear Implants

Severe to profound HL

Usage

ofde

vices

Degree of hearing loss

Hearing aids Cochlear implants

Middle earimplants


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Hearing Loss Prevalence

Hearing loss is one of the mostprevalent chronic conditions inthe United States, affecting morethan nine million Americans overthe age of 65 and 10 million

Americans age 45 to 64.

But about three out of five olderAmericans with hearing loss andsix out of seven middle-aged

Americans with hearing loss donot use hearing aids.

Only 1 in 5 use amplification


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Vibrant Soundbridge Middle EarImplant

First FDA-approved MEIfor moderate to severeSNHL

Utilizes direct drivetechnology, offeringa clearer, more naturalsound quality withoutoccluding the ear canal


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Vibrant Soundbridge

A prosthetic devicedesigned for peoplewho:

Are unsuccessful orunable to achieveadequate benefit withhearing aids

Cannot tolerate hearingaids

Medically unable to useconventionalamplification


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Conditions That May PrecludeConventional Amplification

Chronic otitis externa Exostosis

Eczema or psoriasis

Allergies Stenotic canal

Absence of the pinna Mandibular fractures

Excessive waxproduction

Excessive perspiration


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History

Developed in 1996 by Symphonix

Designer Geoff Ball is a bilateral user

FDA approved in 2000

First ME prosthesis to obtain FDA approval

Assets purchased by MED-EL in 2003

Thousands of implants worldwide


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History

After MED-EL purchase,

manufacturing moved to Austria FDA re-approval of the new

manufacturing facility in 2007

US re-launch in 2007

Planned clinical trialsfor expanded use


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Amplification vs. Direct Drive

Amplification issues:

Occlusion, insertion loss,feedback

Direct drive solutions:

Mechanical energy delivereddirectly to the ossicles

Enhances natural vibratory motion

Eliminates many of theacoustic issues inherent intraditional amplification


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Amplification vs. Direct Drive


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Soundbridge Components

Floating MassTransducer

Audio Processorreceiver

Vibrating Ossicular Prosthesis(VORP) implant

Detail of Floating

Mass Transducer

Conductor Link


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Advantages of Direct Drive

Open ear canal for

comfort No occlusion

Low frequencies enter theear naturally

Better hearing inbackground noise

Better cosmetics

Reduction of feedback

Clearer, more naturalsound


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VORP - Vibrating Ossicular Prosthesis


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FMT - Floating Mass Transducer


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Surgery

Similar procedure to

cochlear implants Minimal shaving,

small incision

Outpatient procedure1.5 - 2 hours

AP fit after 8 weeks


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The Audio Processor (AP)

Microphone & digital

signal processor 1 x 675 zinc air battery

for one weeks use

2.5 cm diameter Adjustable magnet

Available in 3 colors


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Audio Processor No occlusion of the ear

canal

Easily hidden under thehair

Held in place bymagnetic attraction

No interference withglasses


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Candidacy

Adults (18+) with bilateralmoderate to severeSNHL 55dB loss maximum at 500

Hz

Word recognition of50% or better With hearing aids at 65dB

SPL

Under headphones at MCL

Normal middle earanatomy

Realistic expectations


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Candidacy


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Who is Not a Candidate?

Conductive/mixed hearing losses

Progressive or sudden hearing loss Active middle ear infection

Tympanic membrane perforation associated with

recurrent middle ear infection

Retrocochlear or central auditory disorder

Skin condition that precludes use of the AP

Unrealistic expectations


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Benefits

High frequency gain without feedback

No insertion loss Elimination of the occlusion effect

Improved comfort and ease of use

Distortion-free signal

No electronic receiver in the ear canal, which is amajor source of distortion with hearing aids


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Benefits

More natural sound quality

Addresses many medical issues Takes advantage of any low frequency residual

hearing

Low frequencies are still transmitted through the earcanal

FMT is designed to be linear

Mimics the natural vibratory pattern of the ossicularchain through 8000 Hz


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Outcomes

US clinical trial on 53 adult subjects

Subjects had moderate-severe SNHL withair/bone gap no greater than 10 dB

All subjects had at least 3 months of

hearing aid experience prior to the study Typical Soundbridge candidates tend to be

experienced hearing aid users who have never been

happy with their aids


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Hearing Device Satisfaction Scale

0% 20% 60% 80% 100%

VibrantVibrant SSoundbridgeoundbridge Hearing AidHearing Aid

Sound QualitySound Quality

of Own Speechof Own Speech

NaturalnessNaturalness

of Speechof Speech

Clearness ofClearness of

Sound ToneSound Tone

Overall SoundOverall SoundQualityQuality

31%

18%

27%

24%

89%89%

86%86%

86%86%

83%83%

40%


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Hearing Device Satisfaction Scale

0% 20% 40% 60% 80% 100%

BackgroundNoise

Cleaning andMaintenance

Overall Fit &Comfort56%

54%

8%


98%98%

98%98%

67%67%


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Satisfaction in Specific ListeningEnvironments

0% 20% 40% 60% 80% 100%


TelevisionTelevision

TheaterTheater

MoviesMovies

Enjoyment ofEnjoyment ofMusicMusic

27%

20%

13%

29%

80%80%

86%86%

82%82%

78%78%


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Summary of Benefits

Better sound quality

Improved comfort No feedback

Better hearing in background noise

No clinically significant impact on residualhearing


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Device Warranty

New, increased warranty coverage

3 years for AP (previously 2) 5 years for VORP

Loss and damage 1x Loss and Damage for AP during original

manufacturers warranty (newly implanted patients)

ESCO Limited Theft/Loss ($250/yr)

Repairs

$150 flat rate with 6 mo warranty on AP ESCO Repair Coverage (additional $75)


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Reimbursement

MED-EL Reimbursement Mission:

Secure third party coverage for VBS withpayment levels commensurate with devicepricing

Re-introduction of VSB as a Middle EarProsthesis

Expanded FDA indications to individuals who

Receive no adequate benefit from HA Cannot medically tolerate HA


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Reimbursement

Reclassification as a prosthetic device (2006) Middle ear prosthetics should be covered if

Medically necessary

Documented in patients medical record with diagnosticcodes

Coding recommendations

L code for prosthetic implants


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MED-EL Reimbursement Manualfor the Vibrant Soundbridge

Free guidance documentdesigned to assistclinicians and billing staff

with obtainingreimbursement for theVSB

Step-by-step instructions

and templates


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Reimbursement

MED-EL reimbursement department services:

Provider education and follow-up Clinic visits, training to hospital billing staff, claims tracking

Reimbursement services

Personalized assistance for pre-authorization, appeals, etc.

Collect reimbursement data to support application forbetter CPT codes

Track charge, payment and utilization history across the country

Customer support is invaluable in this effort!


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Summary

Proven long term experience

FDA approved since 2000

Safe and effective

Excellent proven clinical results

High level of patient satisfaction

No impact on residual hearing


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Summary

Appropriate for patients seeking

alternatives to traditionalamplification due to

Sound quality issues

Occlusion issues Feedback issues

Medical contraindicationsto hearing aid use


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For More Information

www.vibrant-medel.com

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