Semi-Implantable and Fully Implantable Middle Ear Hearing Aids

POLICY NUMBER

A.7.01.84

DESCRIPTION

Moderate-to-severe sensorineural hearing loss is often treated with external acoustic hearing aids, while conductive hearing loss can be treated with acoustic or bone-conduction hearing aids when surgical or medical interventions do not correct hearing loss. Semi-implantable and fully implantable middle ear hearing aidsdetect 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

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 detection thresholds as mild (20-40 dB), moderate (40-60 dB), severe (60-80 dB), and profound (≥80 dB).

Treatment

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 the 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- and Fully Implantable Middle Ear Hearing Aids

Semi-implantable and fully implantable middle ear hearing aids are alternatives to external acoustic hearing aids. Two semi-implantable devices have the U.S. Food and Drug Administration (FDA) approval: the Vibrant Soundbridgeand the Maxum System. The devices consist of components: a magnet 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 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 the FDA approval: the Esteem Implantable Hearing System. 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 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 (MED-EL Corp.) in 2000 and the Direct System™ (Soundtec) in 2001. The Soundtec System was discontinued by the manufacturer Ototronix in 2004 due to performance issues; it was re-released in 2009 under the name Maxum System. The approved FDA labeling for both 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 2010, the Esteem Implantable Hearing System (Envoy Medical, St. Paul, MN), a fully implantable middle ear hearing aid, was approved by the 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.”

Another fully implantable middle ear hearing aid, the Carina® Fully Implantable Hearing Device, is in development (Otologics, now Cochlear), but does not have the FDA approval. Phase 1 and 2 trials have been conducted in the United States under investigational device exemptions.

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.

POLICY

Semi-implantable and fully implantable middle ear hearing aids are considered investigational.

POLICY EXCEPTIONS

Federal 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 GUIDELINES

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

Determining Recipient Selection Criteria: (The package insert of the Vibrant® Soundbridge™ device describes the following recipient selection criteria.)

• Pure-tone air-conduction threshold levels that fall at or within the limits outlined in the table below.

• 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.

Pure-Tone Air-Conduction Threshold Levels

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 individuals have experience with appropriately fitted hearing aids.

The Esteem® device is indicated for individuals with hearing loss meeting the following criteria:

• 18 years of age or older

• Stable bilateral sensorineural hearing loss

• Moderate (40-70 dB) to severe (71-90 dB) sensorineural hearing loss defined by pure-tone average

• 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 computed tomography scan

• Minimum 30 days of experience with appropriately fit hearing aids.

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. 

POLICY HISTORY

5/5/2008: 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.

05/31/2016: Policy number A.7.01.84 added.

02/27/2017: Policy description updated regarding devices. Patient selection criteria moved to the Policy Guidelines section. Policy statement unchanged.

03/01/2018: Policy reviewed; no changes.

03/25/2019: Policy reviewed; no changes.

03/11/2020: Policy reviewed; no changes.

05/20/2021: Policy reviewed. Policy statement unchanged. Policy Guidelines updated regarding pure-tone air conduction threshold levels.

04/22/2022: Policy description updated. Policy statement unchanged.

03/22/2023: Policy reviewed. Policy statement unchanged. Policy Guidelines updated with minor wording changes.

03/21/2024: Policy reviewed. Policy statement unchanged. Policy Guidelines updated regarding devices.

04/14/2025: Policy description updated. Policy statement unchanged. Policy Guidelines updated.

SOURCE(S)

Blue Cross & Blue Shield Association Policy # 7.01.84

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Investigational Codes

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