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Moderate-to-severe sensorineural hearing loss is often treated with external acoustic hearing aids, while conductive hearing loss may be treated with acoustic or bone conduction hearing aids when surgical or medical interventions are unable to correct hearing loss. Semi-implantable and fully implantable middle ear hearing aids detect sound and transduce signals directly to the ossicles in the middle ear, and have been used as an alternative to external acoustic hearing aids.
Hearing loss is described as conductive, sensorineural, or mixed, and can be unilateral or bilateral. Normal hearing is the detection of sound at or below 20 decibels (dB). The American Speech Language- Hearing Association has defined the degree of hearing loss based on pure tone average (PTA) detection thresholds as mild (20-40 dB), moderate (40-60 dB), severe (60-80 dB), and profound (≥80 dB).
Sound amplification through the use of an air-conduction hearing aid can provide benefit to patients with sensorineural, conductive, or mixed hearing loss. Contralateral routing of signal is a system in which a microphone on the affected side transmits a signal to an air-conduction hearing aid on the normal or less affected side.
Patients with moderate-to-severe sensorineural hearing loss are typically fitted with external acoustic hearing aids. Conductive hearing loss may be treated with acoustic or bone conduction hearing aids when surgical or medical interventions are unable to correct hearing loss. However, these hearing aids may not be acceptable to patients, either due to issues related to anatomic fit, sound quality, or personal preference. In some cases, external acoustic hearing aids cannot be used due to external ear pathologies (eg, otitis externa).
Semi-implantable and fully implantable middle ear hearing aids have been developed as an alternative to external acoustic hearing aids. Two semi-implantable devices have Food and Drug Administration (FDA) approval: the Vibrant Soundbridge (MED-EL Corp.) and the Maxum System (Ototronix). 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. The Soundbridge device is implanted subcutaneously behind the ear while the processor is worn externally on the scalp over the receiver unit and held in place by a magnet. The Maxum System device is placed in the user’s ear canal while 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 (floating mass transducer) 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.
One fully implantable middle ear hearing aid has FDA approval: the Esteem Implantable Hearing System (Envoy Medical). Similar to the semi-implantable devices, the fully implantable device consists of a sensor, a sound processor, and a driver connected to the ossicles. The sensor detects vibrations of the tympanic membrane and transforms the vibrations into electrical signals that are processed by the sound processor. The processor transduces these signals via 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 into electrical signals that are delivered to the stapes by another piezoelectric transducer, the driver.
Two semi-implantable devices were approved by the U.S. Food and Drug Administration (FDA) through the premarket approval process: the Vibrant® Soundbridge™ in August 2000 and the Soundtec® Direct System™ in September 2001. The Soundtec was discontinued by the manufacturer Ototronix in 2004 due to performance issues; it was re-released in 2009 under the name Maxum™ System. The FDA labeling approved for both devices states that the devices 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."
In March 2010, the Esteem® Implantable Hearing System (Envoy Medical, St. Paul, MN), a fully implantable middle ear hearing aid, was approved by FDA through the premarket approval process. 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.” The Esteem device is indicated for patients with hearing loss meeting the following criteria:
Another fully implantable middle ear hearing aid, the Carina® Fully Implantable Hearing Device, was in development (Otologics, Boulder, CO), but does not have FDA approval.
Determining Patient Selection Criteria:
The Maxum System is indicated for use in adults, 18 years of age or older, who have moderate-to-severe sensorineural hearing loss and desire an alternative to an acoustic hearing aid. Before receiving the device, it is recommended that patients have experience with appropriately fitted hearing aids.
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.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
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.
05/07/2014: Policy reviewed; description updated. Policy statement unchanged.
04/09/2015: Policy description updated regarding devices. Policy statement unchanged. Policy guidelines updated to revise investigative definition.
07/23/2015: Code Reference section updated for ICD-10.
03/31/2016: Policy description updated regarding devices. Policy statement unchanged.
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.