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The devices consist of 3 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 user’s 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 Esteem® Implantable Hearing System by Envoy Medical Corporation is a fully implantable middle ear hearing aid that received FDA approval in March 2010. The FDA-approved labeling for the Esteem hearing implant indicates it is “intended to alleviate hearing loss...in adults 18 years of age or older with stable bilateral sensorineural hearing loss.” This device uses piezoelectric transduction as opposed to the electromagnetic transduction used in the semi-implantable devices. A piezoelectric transducer, the sensor, is placed at the head of the incus and converts mechanical vibrations detected from the tympanic membrane to electrical signals that are delivered to the stapes by another piezoelectric transducer, the driver.  The Esteem device is indicated for patients with hearing loss meeting the following criteria:

• 18 year of age or older
• Stable bilateral sensorineural hearing loss
• Moderate (hearing loss between 40 and 70 dB) to severe (hearing loss between 71 and 90 dB) sensorineural hearing loss defined by Pure Tone Average (PTA)
• Unaided speech discrimination test score greater than or equal to 40%
• Normally functioning eustachian tube
• Normal middle ear anatomy
• Normal tympanic membrane
• Adequate space for Esteem implant determined via high resolution CT scan
• Minimum 30 days of experience with appropriately fit hearing aids.

Determining Patient Selection Criteria:
(The package insert of the Vibrant Soundbridge™ device describes the following patient selection criteria)

• Pure-tone air-conduction threshold levels shall fall at or within:

• Word recognition score of 50% or better, using recorded material
• Normal middle ear anatomy
• Psychologically and motivationally suitable with realistic expectations of the benefits and limitations of the device

(The package insert of the Soundtec® Direct System describes the following audiologic patient selection criteria)

See the Cochlear Implants policy, for the treatment of severe to profound deafness.

See the Implantable Bone-Conduction and Bone Anchored Hearing Aids policy, for the treatment of hearing loss.

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

12/09/2009: Description Section revised to add Patient Selection Criteria guidelines. Policy Statement revised to add Investigative Service definition and Benefit Plan Language Verbiage. Policy Exceptions updated with FEP verbiage.

08/03/2011: Policy description updated regarding available devices. Added "fully implantable" to the policy title and statement.

05/09/2012: Policy title changed from "Hearing Aid for Moderate to Severe Sensorineural Hearing Loss" to "Semi-Implantable and Fully Implantable Middle Ear Hearing Aids" to reflect the scope of the policy. Policy statement unchanged.

All codes billed for this procedure are considered investigational and not eligible for coverage.

Non-Covered Codes