Download Implanted Devices for Hearing Loss

JOHNS HOPKINS HEALTHCARE
Medical Policy: Implanted Devices for
Hearing Loss
Department: Medical Management
Lines of Business: EHP, USFHP, PPMCO
Policy Number: CMS03.10
Effective Date: 06/06/2014
Review Date: 06/06/2014
Page 1 of 9
ACTION:
New Policy: CMS02.11 & CMS03.04 Combined
Revising Policy Number
Superseding Policy Number
Archiving Policy Number
Retiring Policy Number
Johns Hopkins HealthCare provides a full spectrum of health care products and services for Employer
Health Programs, Priority Partners, and US Family Health Plan. Each line of business possesses its own
unique contract and guidelines which, for benefit and payment purposes, should be consulted to know what
benefits are available for reimbursement. Specific contract benefits, guidelines or policies supersede the
information outlined in this policy.
POLICY:
This policy does not address air conduction hearing aids.
For US Family Health Plan see TRICARE Policy Manual 6010.57-M, February 1, 2008, Cochlear
Implantation: Chapter 4, Section 22.2 and Hearing Aids and Hearing Aid Services: Chapter 7, Section 8.2.
I.
Cochlear Implants
A. When benefits are provided under the member’s contract, JHHC considers cochlear implants
medically necessary for children ≥12 months of age when all of the following criteria are met:
1.
Diagnosis of bilateral severe to profound sensorineural hearing loss, defined as a puretone average hearing threshold of ≥70 decibels (dB) at 500, 1000, and 2000 Hertz (Hz);
and
2.
Limited or no benefit from appropriately fitted binaural hearing aids; defined by the
following:
a. In young children, failure of auditory skill progression or speech and language
development; or
b. In older children, a score of ≤30% in an open-set sentence or spoken word
recognition test under best aided conditions; or
c. In adults, a score of ≤50% in an open-set sentence recognition test under best aided
conditions; and
3.
Documentation of patient’s ability and willingness to participate in a rehabilitation
program consisting of at least 6 sessions during which speech recognition, understanding,
and perception are developed and tested; and
4.
No evidence of the following contraindications:
a. Active or chronic middle ear infection; or
Review Dates: 6/6/14
JOHNS HOPKINS HEALTHCARE
Medical Policy: Implanted Devices for
Hearing Loss
Department: Medical Management
Lines of Business: EHP, USFHP, PPMCO
Policy Number: CMS03.10
Effective Date: 06/06/2014
Review Date: 06/06/2014
Page 2 of 9
b.
c.
B.
C.
Hearing loss due to lesions of the acoustic nerve or central auditory pathway; or
Absent cochlear development, cochlear ossification, or inaccessible cochlear lumen;
or
d. Contraindication(s) to surgery.
Bilateral implantation may be considered medically necessary in individuals meeting the above
criteria in whom it has been determined that use of a hearing aid in the non-implanted ear will
not result in binaural benefit.
Cochlear implants must be used according to FDA-approved indications.
II.
Auditory Brainstem Implants
A. When benefits are provided under the member’s contract, JHHC considers auditory brainstem
implants medically necessary for individuals ≥12 years of age when the following criteria are
met:
1.
Diagnosis of neurofibromatosis type II; and
2.
Deafness due to bilateral resection of auditory nerve tumors.
III.
Bone Anchored Hearing Devices
A. When benefits are provided under the member’s contract, JHHC considers bone anchored
hearing devices (also referred to as osseointegrated implants or BAHA) medically necessary for
individuals ≥5 years of age when the following criteria are met:
1.
For unilateral sensorineural hearing loss:
a. A pure-tone average hearing threshold of ≥70 dB at 500, 1000, and 2000 Hz; and
b. Normal hearing (a pure-tone average hearing threshold of <20 dB) in the other ear;
and
c. A failed trial of nonsurgical augmentation (such as a contralateral routing of signals
aid) unless contraindicated or inappropriate; or
2.
For unilateral or bilateral conductive or mixed hearing loss:
a. An inability for air conduction hearing aids to effectively restore hearing due to the
presence of at least one of the following conditions:
i.
Congenital or surgical malformation of the external ear or canal; or
ii.
Chronic otitis or dermatitis of the external ear; or
iii. Tumor of the external ear canal or tympanic cavity; or
iv. Hearing loss secondary to otosclerosis in individuals who are not stapedectomy
candidates; or
v.
Other condition in which an air-conduction hearing aid is contraindicated or
inappropriate; and
b. A pure-tone average bone conduction threshold of ≤65 dB at 500, 1000, 2000, and
3000 Hz in the affected ear(s); and
c. A speech discrimination score of ≥60%.
B. Bilateral implantation may be considered medically necessary if the above criteria are met and
conductive or mixed hearing loss is bilateral and symmetric (defined as an average difference in
bone conduction threshold of <10 dB between the right and left at 500, 1000, 2000, and 3000
Review Dates: 6/6/14
JOHNS HOPKINS HEALTHCARE
Medical Policy: Implanted Devices for
Hearing Loss
Department: Medical Management
Lines of Business: EHP, USFHP, PPMCO
C.
Policy Number: CMS03.10
Effective Date: 06/06/2014
Review Date: 06/06/2014
Page 3 of 9
Hz or <15 dB at individual frequencies).
Bone anchored hearing devices must be used according to FDA-approved indications.
IV.
Other Devices for Hearing Loss
A. JHHC considers the following devices to be experimental and investigational:
1.
Cochlear hybrid implants (such as Nucleus Hybrid);
2.
Semi-implantable electromagnetic hearing aids (such as Vibrant Soundbridge);
3.
Totally implanted hearing systems (such as Esteem);
4.
Magnetically coupled partially implantable bone conduction hearing systems (such as
Otomag Alpha 1);
5.
Intra-oral bone conduction hearing aids (such as SoundBite)
6.
Hearing devices and accessories utilizing Bluetooth technology.
V.
Replacement Devices, Parts, and Components
A. Replacement of the above devices and components is generally considered medically necessary
only when the existing device or component is defective or malfunctioning. Replacements are
not considered medically necessary when the current device or component is functional or
when requested for convenience, aesthetics, or to upgrade to newer technology.
BACKGROUND:
Normal hearing is categorized by the recognition of sound at less than 20 dB; however, most individuals
with normal hearing can register sound at less than 10 dB. The pure-tone threshold (PTT) is defined by the
softest sound audible by the patient at least 50% of the time in a testing situation. In normal hearing, it is
generally consistent for sounds between 250 and 8000 Hz, a range representing the majority of the speech
spectrum. Hearing loss can manifest as increased PTTs at any or all of these frequencies and is categorized
according to the average PTT across the range of frequencies tested. Degree of hearing loss can be
classified as mild (20-39 dB), moderate (40-69 dB), severe (70-89 dB) or profound (90 dB or more).
Normal hearing requires numerous anatomic structures and involves both mechanical and neural processes,
allowing for different types of hearing loss to exist. Conductive hearing loss occurs when sound is not
conducted correctly through the ear due to obstruction, infection, failure of the middle ear bones, or other
causes. Sensorineural hearing loss (SNHL), which is often related to noise exposure and age, most
commonly results from damage to or loss of the cochlear hair cells. Mixed hearing loss involves
components of both conductive and SNHL. In central deafness, the brain’s auditory centers are affected.
Diagnostic testing prior to implantation of a hearing device can include audiologic tests, medical and
psychological evaluation, and imaging studies. Numerous additional tests can aid in determining the most
appropriate management for hearing loss and serve as methods for reporting outcomes in research settings.
Speech-recognition tests, such as the Hearing in Noise Test, assess word or sentence recognition.
Audiologic testing in young children can be complex due to ongoing linguistic and cognitive development.
Review Dates: 6/6/14
JOHNS HOPKINS HEALTHCARE
Medical Policy: Implanted Devices for
Hearing Loss
Department: Medical Management
Lines of Business: EHP, USFHP, PPMCO
Policy Number: CMS03.10
Effective Date: 06/06/2014
Review Date: 06/06/2014
Page 4 of 9
Evaluation may include open- and closed-set word and sentence recognition tests, behavior scales, and
parental reporting, among other assessments.
Removable external hearings aids, while appropriate and effective for many patients with hearing loss, may
not be beneficial for those with conditions impeding use of conventional hearing aids, in certain types of
hearing loss, and in other circumstances.
A cochlear implant is designed for use in certain individuals with prelingual or postlingual SNHL.
Externally, sound picked up by a microphone is carried to a sound processor that transforms the sound to
electrical impulses. These signals are transmitted to a receiver implanted under the skin near the ear and
subsequently to an electrode array near the cochlea. By stimulating the auditory nerve, current from the
electrode array allows the absent or dysfunctional cells of the cochlea to be bypassed. Cochlear implant
devices from three manufacturers are approved for use in the U.S., including subsequent generations with
improved design of various components. While initially restricted to unilateral use in adults, indications for
cochlear implants have progressively broadened as growing evidence demonstrates safety and efficacy in
young patients and improved auditory outcomes when used bilaterally. Following implantation, cochlear
implant programming (and often reprogramming), training, and auditory habilitation or rehabilitation, are
necessary to fully benefit from the device. The advantages in children are generally not realized
immediately; rather, they are established over time – often years.
Semi-implanted and fully implanted middle ear hearing aids were designed as an alternative to externally
worn hearing aids. Like cochlear implants, they are intended for use in SNHL. The former utilizes an
external microphone to receive sound and delivers a corresponding electrical signal to a coil in the ear
canal. The electromagnetic field produced by the coil stimulates a magnet attached to the ossicular chain,
causing vibrations similar to those produced in normal hearing. The fully implanted system uses an internal
sound processor, a sensor, and a driver to transmit signals to the inner ear.
Individuals with neurofibromatosis type II may be rendered deaf due to surgical removal of tumors
involving the auditory nerve. In these cases, an auditory brainstem implant can be used to restore hearing
via a system that bypasses the internal ear and auditory nerve. The implant uses an external speech
processor that transfers a signal to an electrode array in the brainstem, which in turn stimulates the cochlear
nucleus and is processed by the brain. One auditory brainstem implant has been approved by the FDA.
During surgery, a receiver/stimulator is implanted behind the ear and is connected by a wire to a series of
electrodes that are implanted in the brainstem. Externally worn components include a speech processor and
a microphone/headset.
Some patients cannot benefit from conventional air conduction hearing aids because of a medical condition
that precludes proper fitting or limits the ability to effectively restore hearing. In these cases, bone
conduction is often a practical alternative. As with air conduction, bone conduction of sound stimulates the
cochlea; however, more energy is required for stimulation. An implantable bone anchored hearing device is
comprised of an external sound processor that attaches to a small, surgically placed titanium abutment that
osseointegrates with the skull and transmits sound waves through the bone. Individuals with conductive and
Review Dates: 6/6/14
JOHNS HOPKINS HEALTHCARE
Medical Policy: Implanted Devices for
Hearing Loss
Department: Medical Management
Lines of Business: EHP, USFHP, PPMCO
Policy Number: CMS03.10
Effective Date: 06/06/2014
Review Date: 06/06/2014
Page 5 of 9
mixed hearing loss can benefit from bone anchored hearing implants. Numerous osseointegrated implant
systems are FDA-approved, though they differ to some extent in the ranges of hearing loss for which they
are indicated. Bone anchored hearing aids are also approved for use in unilateral SNHL in patients who
cannot use an air conduction contralateral routing of signals aid. A partially implantable system, which was
recently approved by the FDA, uses magnets to adhere the processors to the implant and, therefore, lacks
any component that penetrates the skin. Intraoral bone conduction hearing systems operate via the same
principal as an osseointegrated implant, but utilize the teeth to deliver sound through the bones to the
cochlea.
CODING INFORMATION:
CPT Copyright 2014 American Medical Association. All rights reserved. CPT is a registered trademark
of the American Medical Association.
Note: The following CPT/HCPCS codes are included below for informational purposes. Inclusion or
exclusion of a CPT/HCPCS code(s) below does not signify or imply member coverage or provider
reimbursement. The member's specific benefit plan determines coverage and referral requirements.
All inpatient admissions require pre-authorization.
PRE-AUTHORIZATION REQUIRED
Compliance with the provision in this policy may be monitored and addressed through
post-payment data analysis and/or medical review audits
Employer Health
Programs (EHP) **See
Specific Summary Plan
Description (SPD)
CPT ®
CODES
69710
69714
69715
69717
Priority Partners (PPMCO)
refer to COMAR guidelines
and PPMCO SPD then
apply policy criteria
US Family Health Plan (USFHP),
TRICARE Medical Policy supersedes
JHHC Medical Policy. If there is no Policy
in TRICARE, apply the Medical Policy
Criteria
DESCRIPTION
Implantation or replacement of electromagnetic bone conduction hearing device in temporal
bone (Replacement procedure includes removal of old device)
Implantation, osseointegrated implant, temporal bone, with percutaneous attachment to external
speech processor/cochlear stimulator; without mastoidectomy
Implantation, osseointegrated implant, temporal bone, with percutaneous attachment to external
speech processor/cochlear stimulator; with mastoidectomy
Replacement (including removal of existing device), osseointegrated implant, temporal bone,
with percutaneous attachment of external speech processor cochlear stimulator; without
mastoidectomy
Review Dates: 6/6/14
JOHNS HOPKINS HEALTHCARE
Medical Policy: Implanted Devices for
Hearing Loss
Department: Medical Management
Lines of Business: EHP, USFHP, PPMCO
69718
69930
HCPCS
CODE
L8614
L8619
L8627
L8690
L8691
S2235
Policy Number: CMS03.10
Effective Date: 06/06/2014
Review Date: 06/06/2014
Page 6 of 9
Replacement (including removal of existing device), osseointegrated implant, temporal bone,
with percutaneous attachment of external speech processor cochlear stimulator; with
mastoidectomy
Cochlear device implantation, with or without mastoidectomy
DESCRIPTION
Cochlear device, includes all internal and external components
Cochlear implant external speech processor, replacement
Cochlear implant, speech processor, component, replacement
Auditory osseointegrated device, includes all internal and external components
Auditory osseointegrated device, external sound processor, replacement
Implantation of auditory brain stem implant
NO PRE-AUTHORIZATION REQUIRED
Compliance with the provision in this policy may be monitored and addressed through
post-payment data analysis and/or medical review audits Employer Health
Programs (EHP) **See
Specific Summary Plan
Description (SPD) CPT ®
CODES 69711 92601
92602
92603
92604
92640
HCPCS
CODE
L8615
L8616
L8617
L8618
L8621
L8622
Priority Partners (PPMCO)
refer to COMAR guidelines
and PPMCO SPD then apply
policy criteria US Family Health Plan (USFHP),
TRICARE Medical Policy supersedes
JHHC Medical Policy. If there is no
Policy in TRICARE, apply the
Medical Policy Criteria
DESCRIPTION Removal or repair of electromagnetic bone conduction hearing device in temporal bone
Diagnostic analysis of cochlear implant, patient younger than 7 years of age; with
programming Diagnostic analysis of cochlear implant, patient younger than 7 years of age; subsequent
reprogramming Diagnostic analysis of cochlear implant, age 7 years or older; with programming
Diagnostic analysis of cochlear implant, age 7 years or older; subsequent reprogramming
Diagnostic analysis with programming of auditory brainstem implant DESCRIPTION
Headset/headpiece for use with cochlear implant device, replacement
Microphone for use with cochlear implant device, replacement
Transmitting coil for use with cochlear implant device, replacement
Transmitter cable for use with cochlear implant device, replacement
Zinc air battery for use with cochlear implant device, replacement, each
Alkaline battery for use with cochlear implant device, any size, replacement, each
Review Dates: 6/6/14
JOHNS HOPKINS HEALTHCARE
Policy Number: CMS03.10
Effective Date: 06/06/2014
Review Date: 06/06/2014
Medical Policy: Implanted Devices for
Hearing Loss
Department: Medical Management
Lines of Business: EHP, USFHP, PPMCO
L8623
L8624
L8628
L8629
L8693
V5273
Page 7 of 9
Lithium ion battery for use with cochlear implant device speech processor, other than ear level,
replacement, each
Lithium ion battery
Cochlear implant, external controller component, replacement
Transmitting coil and cable, integrated, for use with cochlear implant device, replacement
Auditory osseointegrated device, abutment, any length, replacement only
Assistive listening device, for use with cochlear implant
REFERENCES:
PRIMARY SCIENTIFIC CLINICAL RESEARCH REFERENCE ARTICLES
1.
2.
3.
4.
5.
6.
7.
8.
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Barbara M, Biagini M, Monini S. The totally implantable middle ear device Esteem for
rehabilitation of severe sensorineural hearing loss. Acta Otolaryngol. 2011; 131:399.
Bond M, Elston J, Mealing S, et al. Systematic reviews of the effectiveness and costeffectiveness of multi-channel unilateral cochlear implants for adults. Clin Otoloaryngol. 2010;
35(2): 87-96.
Brito R, Monteiro T, Leal A, et al. Surgical complications in 550 consecutive cochlear
implantation. Braz J Otorhinolaryngol. 2012;78(3):80-5.
Christensen L, Richter GT, Dornhoffer JL. Update on bone-anchored hearing aids in pediatric
patients with profound unilateral sensorineural hearing loss. Arch Otolaryngol Head Neck Surg.
2010;136(2):175-7.
Colletti V, Carner M, Miorelli V, et al. Auditory brainstem implant (ABI): new frontiers in adults
and children. Otolaryngol Head Neck Surg. 2005;133(1):126-38.
Colquitt JL, Loveman E, Baguley DM, et al. Bone-anchored hearing aids for people with bilateral
hearing impairment: a systematic review. Clin Otolaryngol. 2011;36(5):419-41.
Gaylor JM, Raman G, Chung M, et al. Cochlear implantation in adults: a systematic review and
meta-analysis. JAMA Otolaryngol Head Neck Surg 2013;139:265.
Gluth MB, Eager KM, Eikelboom RH, et al. Long-term benefit perception, complications, and
device malfunction rate of bone-anchored hearing aid implantation for profound unilateral
sensorineural hearing loss. Otol Neurotol. 2010;31(9):1427-34.
Janssen RM, Hong P, Chadha NK. Bilateral bone-anchored hearing aids for bilateral permanent
conductive hearing loss: a systematic review. Otolaryngol Head Neck Surg 2012;147(3):412-22.
Peters BR, Wyss J, Manrique M. Worldwide trends in bilateral cochlear implantation.
Laryngoscope 2010; 120 Suppl 2:S17.
Sparreboom M, van Schoonhoven J, van Zanten BG, et al. The effectiveness of bilateral cochlear
implants for severe to profound deafness in children: a systematic review. Otol Neurotol.
2010;31(7):1062-71.
Zeitler DM, Snapp HA, Telischi FF, et al. Bone-anchored implantation for single-sided deafness
in patients with less than profound hearing loss. Otolaryngol Head Neck Surg. 2012;147(1):
105-11.
Review Dates: 6/6/14
JOHNS HOPKINS HEALTHCARE
Medical Policy: Implanted Devices for
Hearing Loss
Department: Medical Management
Lines of Business: EHP, USFHP, PPMCO
Policy Number: CMS03.10
Effective Date: 06/06/2014
Review Date: 06/06/2014
Page 8 of 9
CLINICAL TECHNOLOGY RESEARCH AND CONSULTING REFERENCES
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American Speech-Language-Hearing Association (ASHA). Working Group on Cochlear
Implants. Cochlear Implants. ASHA Technical Report. Rockville, MD: ASHA; 2004:1-35.
http://www.asha.org/policy/TR2004-00041.htm. Accessed April 3, 2014.
Hayes, Inc. Hayes brief. Esteem Totally Implantable Hearing System (Envoy Medical Corp.) for
Treatment of Moderate to Severe Sensorineural Hearing Loss in Adults. Lansdale, PA: Hayes,
Inc. February 10, 2012.
Hayes, Inc. Medical Technology Directory. Bilateral Cochlear implantation in Children.
Lansdale, PA: Hayes, Inc. July 15, 2013.
Hayes, Inc. Medical Technology Directory. Bilateral Cochlear implantation in Adults. Lansdale,
PA: Hayes, Inc. July 15, 2013.
Hayes, Inc. Medical Technology Directory. Bone-Anchored Hearing Aids. Archived on July 3,
2010.
Hayes, Inc. Medical Technology Directory. Semi-Implantable Electromagnetic Hearing Aids.
Lansdale, PA: Hayes, Inc. April 8, 2011.
Hayes, Inc. Search & Summary. Cochlear Implants in Combination with Bluetooth Technology
for Hearing Impairment in Children. Lansdale, PA: Hayes, Inc. March 6, 2014.
Hayes, Inc. Search & Summary. SoundBite Hearing System (Sonitus Medical Inc.). Lansdale,
PA: Hayes, Inc. January 2, 2013.
HEALTH PLAN REFERENCES
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Aetna. Clinical Policy Bulletin: Bone-Anchored Hearing Aid. Document No. 0403.
http://www.aetna.com/cpb/medical/data/400_499/0403.html. Accessed April 3, 2014.
Aetna. Clinical Policy Bulletin: Cochlear Implants and Auditory Brainstem Implants. Document
No. 0013. http://www.aetna.com/cpb/medical/data/1_99/0013.html. Accessed April 3, 2014.
Aetna. Clinical Policy Bulletin: Implantable Hearing Aids. Document No. 0612.
http://www.aetna.com/cpb/medical/data/600_699/0612.html. Accessed April 3, 2014.
Cigna. HealthCare Coverage Position: Cochlear and Auditory Brainstem Implants. Document
No. 0190.
https://my.cigna.com/teamsite/health/provider/medical/procedural/coverage_positions/medical/
mm_0190_coveragepositioncriteria_cochlear_and_auditory_brainstem_implants.pdf. Accessed
April 3, 2014.
Cigna. HealthCare Coverage Position: Hearing Aids. Document No. 0093.
https://cignaforhcp.cigna.com/public/content/pdf/coveragePolicies/medical/mm_0093_coverage
positioncriteria_hearing_aids.pdf. Accessed April 3, 2014.
REGULATORY GOVERNMENT REFERENCES
26.
Centers for Medicare & Medicaid Services (CMS). Medicare Coverage Database. NCD for
Cochlear Implantation (50.3). Effective April 4, 2005.
Review Dates: 6/6/14
JOHNS HOPKINS HEALTHCARE
Medical Policy: Implanted Devices for
Hearing Loss
Department: Medical Management
Lines of Business: EHP, USFHP, PPMCO
27.
28.
29.
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Policy Number: CMS03.10
Effective Date: 06/06/2014
Review Date: 06/06/2014
Page 9 of 9
http://www.cms.hhs.gov/mcd/index_list.asp?list_type=ncd. Accessed April 3, 2014.
Maryland Office of the Secretary of State. COMAR Online, 10.09.51-10.21.08.03, Early and
Periodic Screening, Diagnosis, and Treatment (EPSDT) Audiology Serves.
http://www.dsd.state.md.us/comar/searchall.aspx. Accessed April 3, 2014.
Raman, G, Lee, J, Chung, M. et al. Effectiveness of Cochlear Implants in Adults with
Sensorineural Hearing Loss. Technology Assessment Report. April 2011.
http://www.cms.gov/determinationprocess/downloads/id80TA.pdf. Accessed April 3, 2014.
TRICARE Policy Manual 6010.57-M, February 1, 2008, Cochlear Implantation: Chapter 4,
Section 22.2 and Hearing Aids and Hearing Aid Services: Chapter 7, Section 8.2. Retrieved
from: http://manuals.tricare.osd.mil/DisplayManual.aspx?SeriesId=T3TPM&TP08=87#TP08
U.S. Food and Drug Administration, Center for Devices and Radiological Health, New Device
Approvals; Nucleus 24 Auditory Brainstem Implant System-P000015.
U.S. Food and Drug Administration. Center for Devices and Radiological Health. Cochlear
implants. April 30, 2009.
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/C
ochlearImplants. Accessed April 3, 2014.
U.S. Food and Drug Administration. Esteem Implantable Hearing System. FDA Summary of
Safety and Effectiveness.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=P090018.
Accessed April 3, 2014.
U.S. Food and Drug Administration. Medical Devices: Other Products and Devices to Improve
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http://www.fda.gov/medicaldevices/productsandmedicalprocedures/homehealthandconsumer/c
onsumerproducts/hearingaids/ucm181482.htm. Accessed April 3, 2014.
U.S. Food and Drug Administration. Section 2. Summary and Certification. 510(k) Summary
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U.S. Food and Drug Administration. Vibrant Soundbridge. FDA Summary of Safety and
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Accessed April 3, 2014.8
Review Dates: 6/6/14