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Date Printed: June 26, 2017: 11:36 AM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

02-69000-05

Original Effective Date: 08/15/03

Reviewed: 08/27/09

Revised: 11/01/15

Subject: Semi-Implantable Middle Ear Hearing Aids

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
Other References Updates

DESCRIPTION:

Patients with moderate to severe sensorineural hearing loss are typically fitted with external acoustic hearing aids. However, these hearing aids may not be acceptable to patients, either due to issues related to anatomic fit, sound quality, or personal preference. A semi-implantable middle ear hearing aid has been developed as an alternative to external acoustic hearing aids. Two such devices have received FDA approval, the Vibrant┬« Soundbridge™, approved in August of 2000, and the Soundtec┬« Direct System™, approved in September 2001. The FDA label for both devices states that they are intended for use in adults, 18 years of age or older, who have a moderate to severe sensorineural hearing loss and desire an alternative to an acoustic hearing aid.

The devices consist of three components: a magnetic component that is implanted onto the ossicles of the middle ear, a receiver, and a sound processor. In the Soundbridge the device is implanted subcutaneously behind the ear, while the Soundtec device is placed in the ear canal. In the Soundbridge device the processor is worn externally on the scalp over the receiver unit, held in place by a magnet, while in the Soundtec device, the processor rests over the external ear. In general the sound processor receives and amplifies the sound vibrations and transforms the sound pressure into electrical signals that are received by the receiver unit. The receiver unit then transduces these electrical signals into electromagnetic energy and creates an alternating electromagnetic field with the magnetic component implanted on the ossicles of the middle ear. This electromagnetic field results in attractive and repulsive forces on the magnetic implant, causing vibration of the bones of the middle ear similar to normal hearing.

The limited data suggest semi-implantable middle ear hearing aids may provide a marginal improvement in hearing compared to conventional external acoustic hearing aids. The clinical significance of the improvement in functional gain and speech perception is uncertain. While safety concerns appear to be minimal, only a limited number of patients were included in the clinical trials, and few have completed more than 1year follow-up. Given the small number of patients and the limited safety data, risks cannot be adequately evaluated and compared with the marginal improvement in hearing.

POSITION STATEMENT:

Semi-implantable middle ear hearing aids are considered experimental or investigational, as there is insufficient evidence to support conclusions regarding the effects of semi-implantable hearing aids on health outcomes. The clinical significance of the improvement in functional gain and speech perception is uncertain and there is a lack of adequate safety data in broader patient populations over a longer period of time.

BILLING/CODING INFORMATION:

HCPCS Coding:

S2230

Implantation of magnetic component of semi-implantable hearing device on ossicles in middle ear (investigational)

V5095

Semi-implantable middle ear hearing prosthesis (investigational)

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

Cochlear Implants, 02-69000-03

OTHER:

Other names used to report semi-implantable middle ear hearing aids:

Note: The use of specific product names is illustrative only. It is not intended to be a recommendation of
one product over another, and is not intended to represent a complete listing of all products available.

Implantable middle ear hearing device
Soundbridge device
Soundtec device
Vibrant Soundbridge

REFERENCES:

  1. Blue Cross Blue Shield Association. Medical Policy Reference Manual. Semi-Implantable Middle Ear Hearing Aid for Moderate to Severe Sensorineural Hearing Loss (7.01.84), 04/09/08.
  2. Blue Cross Blue Shield of Florida physician consultant, 05/02.
  3. ECRI Target Report-Semi-Implantable Electromagnetic Middle Ear Implants for Moderate to Severe Hearing Loss, 11/01.
  4. Hayes Inc. Hayes Medical Technology Directory Semi-Implantable Electromagnetic Hearing Aids. Lansdale, PA: Hayes, Inc (05/18/05). Updated 05/26/08.
  5. HCPCS Level II Ingenix, (current edition).
  6. Hough JV, Matthews P, Wood MW et al. Middle Ear Electromagnetic Semi-Implantable Hearing Device: Results of the Phase II SOUNDTEC Direct Sysytem Clinical Trial. Otology & Neurotology 2002; 23 (6): 895-903.
  7. Luetje CM, Brackman D, Balkany TJ et al. Phase III Clinical Trials Results with the Vibrant Soundbridge Implantable Middle Ear Hearing Device: A Prospective Controlled Multicenter Study. Otolaryngology – Head Neck Surgery 2002; 126 (2): 97-107.
  8. Sterkers O, Boucarra D, Labassi S et al. A Middle Ear Implant, the Symphonix Vibrant Soundbridge: Retrospective Study of the First 125 Patients Implanted in France. Otology & Neurotology 2003; 24 (3): 427-436.
  9. U.S. Food and Drug Administration (FDA)-Soundtec Direct System FDA Summary of Safety and Effectiveness, 09/07/01.
  10. U.S. Food and Drug Administration (FDA)-Vibrant Soundbridge FDA Summary of Safety and Effectiveness, 08/31/00.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 08/27/09.

GUIDELINE UPDATE INFORMATION:

08/15/03

Annual review/new guideline. Implanted Devices for Hearing Loss and Aural Rehabilitation guideline 02-69000-02 archived.

10/01/03

Added S2230; HCPCS update.

08/15/05

Scheduled review; no change in coverage statement.

06/15/06

Scheduled review. No change in coverage statement. Updated references.

06/15/07

Scheduled review; reformatted guideline; updated references.

09/15/08

Scheduled review; no change in position statement. Update references.

09/15/09

Scheduled review; no change in position statement.

11/01/15

Revision: ICD-9 Codes deleted.

Date Printed: June 26, 2017: 11:36 AM