Archived Policies - Surgery


Semi-Implantable Middle Ear Hearing Aid for Moderate to Severe Sensorineural Hearing Loss

Number:SUR714.008

Effective Date:07-01-2004

End Date:09-30-2007

Coverage:

Semi-implantable middle ear hearing aids (i.e. Vibrant Soundbridge and Soundtec Direct System) may be considered medically necessary for patients with moderate to severe sensorineural bilateral hearing loss who are unable to use a standard hearing aid device because of at least one of the following anatomic criteria or medical conditions:

  • Congenital or surgically induced malformations(e.g., atresia) of   the external ear canal or middle ear; OR
  • Chronic external otitis or otitis media; OR
  • Tumors of the external canal and/or tympanic cavity; OR
  • Dermatitis of the external canal.

Description:

Patients with moderate to severe sensorineural hearing loss are typically fit with external acoustic hearing aids.  However, these hearing aids may not be acceptable to patients, 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:

  • magnetic component (implanted onto the ossicles of the middle ear),
  • receiver, and
  • 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 and held in place by a magnet.  In the Soundtec device the processor rests over the external ear.  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.

Rationale:

Data suggests 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, although a clear patient preference appears to be for the implantable devices.   However, the semi-implantable middle ear hearing aid does offer clinically significant benefit to adult patients who have moderate to severe sensorineural hearing loss and are unable to wear a conventional external hearing aid due to anatomic or medical conditions.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

None


Medicare Coverage:

Unknown

References:

Vibrant Soundbridge.  FDA Summary of Safety and Effectiveness: www.fda.gov/cdrh/pdf/p990052.html.

Soundtec Direct System.  FDA Summary of Safety and Effectiveness: www.fda.gov/cdrh/pdf/po10023.html.

Luetje CM, Brackman D, et al, Phase III clinical trial results with the Vibrant Soundbridge implantable middle ear hearing device: a prospective controlled multicenter study.  Otolaryngology Head and Neck Surgery, 2002; 126(2):97-107.

Todt I, Seidl RO, et al, Comparison of different vibrant Soundbridge audio processors with conventional hearing AIDS, Otol Neurotol (2002 September) 23(5):669-73.

Semi-Implantable Middle Ear Hearing Aid for Moderate to Severe Sensorineural Hearing Loss.  BCBSA Consortium Health Plan Medical Policy Reference Manual (2002 October 8) Surgery: 7.01.84

Policy History:

Archived Document(s):

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