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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 unable to achieve adequate benefit or medically unable to tolerate HAs
• Cochlear Implants
– Severe to profound HL
Usa
ge o
f devic
es
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 older Americans with hearing loss and six out of seven middle-aged Americans with hearing loss do not use hearing aids.
Only 1 in 5 use amplification
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Vibrant Soundbridge Middle Ear Implant
• First FDA-approved MEI for moderate to severe SNHL
• Utilizes direct drive technology, offeringa clearer, more natural sound quality without occluding the ear canal
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Vibrant Soundbridge
A prosthetic devicedesigned for people who:
– Are unsuccessful or unable to achieve adequate benefit with hearing aids
– Cannot tolerate hearing aids
– 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 wax production
• 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 newmanufacturing 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 in traditional amplification
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Amplification vs. Direct Drive
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Soundbridge Components
Floating Mass Transducer
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 the ear naturally
– Better hearing in background noise
• Better cosmetics
• Reduction of feedback
• Clearer, more natural sound
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VORP - Vibrating Ossicular Prosthesis
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FMT - Floating Mass Transducer
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Surgery
• Similar procedure tocochlear implants
• Minimal shaving,small incision
• Outpatient procedure1.5 - 2 hours
• AP fit after 8 weeks
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The Audio Processor (AP)
• Microphone & digitalsignal processor
• 1 x 675 zinc air batteryfor one week’s 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 the hair
• Held in place by magnetic attraction
• No interference with glasses
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Candidacy
• Adults (18+) with bilateral moderate to severe SNHL – 55dB loss maximum at 500
Hz
• Word recognition of50% or better– With hearing aids at 65dB
SPL
– Under headphones at MCL
• Normal middle ear anatomy
• 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 a major 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 ear canal
• FMT is designed to be linear
– Mimics the natural vibratory pattern of the ossicular chain 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 ofhearing 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 Quality Sound Quality
of Own Speechof Own Speech
Naturalness Naturalness
of Speechof Speech
Clearness of Clearness of
Sound ToneSound Tone
Overall Sound Overall Sound
QualityQuality
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%
Background Noise
Cleaning and Maintenance
Overall Fit & Comfort
56%
54%
8%
VibrantVibrant SSoundbridgeoundbridge Hearing AidHearing Aid
98%98%
98%98%
67%67%
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Satisfaction in Specific Listening Environments
0% 20% 40% 60% 80% 100%
Vibrant Vibrant SSoundbridgeoundbridge Hearing AidHearing Aid
TelevisionTelevision
TheaterTheater
MoviesMovies
Enjoyment of Enjoyment of
MusicMusic
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 residual hearing
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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
manufacturer’s 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 with payment levels commensurate with device pricing
• Re-introduction of VSB as a Middle Ear Prosthesis
• 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 patient’s medical record with diagnostic codes
– Coding recommendations• “L” code for prosthetic implants
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MED-EL Reimbursement Manual for the Vibrant Soundbridge
• Free guidance document designed to assist clinicians and billing staff with obtaining reimbursement for the VSB
• 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 for better 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