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DESCRIPTIONPatients 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, 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 approval by the U.S. Food and Drug Administration (FDA), the Vibrant® Soundbridge™, approved in August 2000, and the Soundtec® Direct System™, approved in September 2001. The FDA-approved labeling 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 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:
Determining Patient Selection Criteria:
(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.
POLICYSemi-implantable and fully implantable middle ear hearing aids are considered investigational.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
POLICY GUIDELINESInvestigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY5/5/2008: Policy added
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.
07/29/2013: Policy reviewed; no changes.
SOURCE(S)Blue Cross & Blue Shield Association Policy # 7.01.84
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.