Vibrant Soundbridge ®

Implantable Hearing System

Kristin M. Avitabile, MS, CCC-A

Clinical Manager, Southeastern U.S.
MED-EL Corporation
 Hearing Technology
• Hearing Aids
– Mild to severe HL
– Problems with feedback
and cosmetics
• Middle Ear Implants

Usage of devices
– Moderate to severe HL Hearing aids Cochlear implants

– For people who are unable

to achieve adequate Middle ear
implants
benefit or medically unable
to tolerate HAs Degree of hearing loss
• Cochlear Implants
– Severe to profound HL
 Hearing Loss Prevalence

Hearing loss is one of the most

prevalent chronic conditions in
the United States, affecting more
than nine million Americans over
the 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

 Vibrant Soundbridge Middle Ear
Implant
• First FDA-approved MEI
for moderate to severe
SNHL
• Utilizes direct drive
technology, offering
a clearer, more natural
sound quality without
occluding the ear canal
 Vibrant Soundbridge

A prosthetic device
designed for people
who:
– Are unsuccessful or
unable to achieve
adequate benefit with
hearing aids
– Cannot tolerate hearing
aids
– Medically unable to use
conventional
amplification
 Conditions That May Preclude
Conventional Amplification
• Chronic otitis externa • Absence of the pinna
• Exostosis • Mandibular fractures
• Eczema or psoriasis • Excessive wax
• Allergies production
• Stenotic canal • Excessive perspiration
 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
 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 trials
for expanded use
 Amplification vs. Direct Drive
• Amplification issues:
– Occlusion, insertion loss,
feedback
• Direct drive solutions:
– Mechanical energy delivered
directly to the ossicles
– Enhances natural vibratory motion
– Eliminates many of the
acoustic issues inherent in
traditional amplification
Amplification vs. Direct Drive
 Soundbridge Components

Audio Processor Vibrating Ossicular Prosthesis

receiver (VORP) implant

Conductor Link

Floating Mass Detail of Floating

Transducer Mass Transducer
 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
VORP - Vibrating Ossicular Prosthesis
FMT - Floating Mass Transducer
 Surgery
• Similar procedure to
cochlear implants
• Minimal shaving,
small incision
• Outpatient procedure
1.5 - 2 hours
• AP fit after 8 weeks
 The Audio Processor (AP)
• Microphone & digital
signal processor
• 1 x 675 zinc air battery
for one week’s use
• 2.5 cm diameter
• Adjustable magnet
• Available in 3 colors
Audio Processor
• No occlusion of the ear
canal
• Easily hidden under the
hair
• Held in place by
magnetic attraction
• No interference with
glasses
 Candidacy
• Adults (18+) with bilateral
moderate to severe
SNHL
– 55dB loss maximum at 500
Hz
• Word recognition of
50% or better
– With hearing aids at 65dB
SPL
– Under headphones at MCL
• Normal middle ear
anatomy
• Realistic expectations
Candidacy
 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
 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
 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
 Outcomes
• US clinical trial on 53 adult subjects
• Subjects had moderate-severe SNHL with
air/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
 Hearing Device Satisfaction Scale

Overall Sound 89%

Quality 18%

Clearness of 86%
Sound Tone 31%

Naturalness 86%
of Speech 27%

Sound Quality 83%

of Own Speech 24%
0% 20% 40% 60% 80% 100%

Vibrant Soundbridge Hearing Aid

 Hearing Device Satisfaction Scale

Overall Fit & 98%

Comfort
56%

Cleaning and 98%

Maintenance
54%

Background
67%
Noise
8%

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

Vibrant Soundbridge Hearing Aid
 Satisfaction in Specific Listening
Environments

Enjoyment of 80%
Music 20%

Movies 86%
27%

Theater 82%
13%

Television 78%
29%
0% 20% 40% 60% 80% 100%

Vibrant Soundbridge Hearing Aid

 Summary of Benefits
• Better sound quality
• Improved comfort
• No feedback
• Better hearing in background noise
• No clinically significant impact on residual
hearing
 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)
 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
 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
 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
 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!
 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
 Summary
• Appropriate for patients seeking
alternatives to traditional
amplification due to
– Sound quality issues
– Occlusion issues
– Feedback issues
– Medical contraindications
to hearing aid use
 For More Information

www.vibrant-medel.com