Humana Implantable and Non-Implantable Hearing Devices Form

Hearing Aids

Hearing aids are the most commonly known devices for assisting an individual with hearing loss. These are external devices worn either just inside the ear or looped over the ear and can be removed by the wearer. Other types of devices (implantable and semi-implantable) have been developed to treat varying types of hearing loss.

Hearing loss is classified by the severity or degree of hearing loss and can be unilateral or bilateral.

There are three main types of hearing loss including:

• Conductive – Caused by disruptions in sound transmission from getting through the outer ear or middle ear to the cochlea, the hollow tube coiled in the shape of a snail’s shell, that changes sound into nerve messages and sends them to the brain.
• Sensorineural hearing loss – Caused by disruptions in sound transmission from the cochlea to the brain. This type of hearing loss occurs when there is an issue with the way the inner ear or hearing nerve works.
• Mixed hearing loss – Caused by a mix of both conductive and sensorineural hearing loss.

Auditory Brainstem Implant

An auditory brainstem implant is a specialized implantable hearing device used in individuals who have had surgical removal of auditory nerve tumors and are totally deaf as a result. Similar to a cochlear implant, it consists of several components: a microphone, which picks up sound and transmits an electrical signal to the speech processor; the speech processor converts the signal to digital impulses, which are sent to a transmitter coil worn behind the ear and directly over the implant that is embedded in the skull.

The implant relays the signals to an electrode placed on the brainstem near the severed auditory nerve; the signals stimulate the brainstem and can be interpreted by the brain in a manner similar to the interpretation of signals normally received from the ear. After surgical placement, the implant must be programmed and tested. The individual must undergo a period of training to recognize sounds and communicate with the device. Currently, the only US Food & Drug Administration (FDA) approved auditory brainstem implant is the Nucleus Profile Plus Auditory Brainstem Implant.

Bone Anchored/Bone Conduction Hearing Aids

A percutaneous bone anchored hearing aid (pBAHA), also known as an osseointegrated mastoid implant, is a type of implantable hearing device based on bone conduction of sound. Certain individuals, typically those with conductive or mixed hearing loss, who are unable to utilize a conventional hearing aid may benefit from this device since it transmits sound directly through the skull. A titanium post is surgically embedded into the skull with a small section, called an abutment, exposed outside of the skin. A sound processor sits on the abutment and transmits sound vibrations via the titanium post. The vibrations stimulate the nerve fibers of the inner ear, which enables hearing.

Examples of bone anchored hearing aids include, but may not be limited to, Baha Connect System and Ponto Bone Anchored Hearing System, both of which have several different sound processor models.

A transcutaneous bone anchored hearing aid (tBAHA), also known as a partially implantable hearing aid, utilizes a magnetic abutment under the skin which is surgically implanted in an outpatient setting. These systems use the magnetic connection to join the sound processor and implant. This device creates an electromagnetic field that vibrates and stimulates the ossicles, sending signals to the cochlea to improve hearing acuity. Examples of transcutaneous bone anchored hearing aids include, but may not be limited to, Alpha 2 MPO ePlus, Baha Attract System, BONEBRIDGE and Osia System.

Cochlear Implant

A cochlear implant is an electronic device that can provide improved speech and hearing communication abilities for an individual who has severe-to-profound, sensorineural hearing loss (SNHL) in both ears and who still has difficulty hearing despite appropriately fitting conventional hearing aids. The implant is surgically placed under the skin, behind the ear. It generally consists of four parts: a microphone, which picks up sound from the environment; a speech processor, which is worn externally or carried and arranges the sound transmitted by the microphone; a receiver/stimulator that receives signals from the speech processor and converts them into electrical impulses; and an electrode, which collects the impulses from the stimulator and sends them to the brain.

Although it cannot restore normal hearing, the cochlear implant enables an individual with profound or total deafness to hear sound, including speech, by stimulating the auditory nerve in the inner ear. Following implantation, the device must be programmed, calibrated and the individual trained to use it. The effectiveness of the implant depends heavily on postoperative rehabilitation that is necessary for the individual to learn to communicate using the device. Examples of cochlear implants include, but may not be limited to, HiRes Ultra/HiRes Ultra 3D Cochlear Implant, Neuro Cochlear Implant System, Nucleus Profile Plus Cochlear Implant System, and Synchrony 2 Cochlear Implant.

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Assistive listening devices purportedly enhance the function of a cochlear implant or hearing aid by helping to separate desired sounds from background noise. These devices generally consist of a microphone to collect sound, a transmitter to send the signal across a distance, a receiver to intercept the signal and any one of several different listening attachments to send the sound from the receiver to the individual’s ear, hearing aid or cochlear implant. (Refer to Coverage Limitations section)

Hybrid cochlear implants purportedly provide both electric (cochlear implant portion) and acoustic (hearing aid portion) stimulation to individuals with severe-to- profound hearing loss that may still hear low frequency sounds. The hybrid implant electrodes are shorter and thinner than cochlear implant electrodes and are implanted only halfway in an effort to preserve the area responsible for low frequency sounds.

An example of a hybrid cochlear implant includes, but may not be limited to, the Nucleus Hybrid Implant System.

(Refer to Coverage Limitations section)

Fully Implantable Middle Ear Hearing System

Fully implantable middle ear hearing systems, in which all components are surgically positioned in the middle ear, are purported to be an alternative to the traditional over the ear hearing aid. The device uses the eardrum like a microphone and there is a sensor placed on the incus. The mechanical motion produced at the incus is then converted into an electrical signal and is sent to the processor which amplifies and filters that signal. Once converted to a vibratory signal it is then transmitted into the inner ear where it is perceived as sound.50 An example of a fully implantable hearing system includes, but may not be limited to, the Esteem Implant.

(Refer to Coverage Limitations section)

Non-Implantable Hearing Devices

Nonimplanted bone conduction devices are intended for children and some adults to use prior to bone anchored hearing aid placement. These include bands or adhesive patches that can be worn over the mastoid bone which purportedly send sound waves through the bone and into the inner ear. Examples of these devices include, but may not be limited to, Baha Softband, Baha SoundArc, ADHEAR and Ponto Softband 5.

(Refer to Coverage Limitations section)

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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

An intraoral bone conduction hearing system consists of two pieces; a processor worn behind the ear and a custom fitted, removable, oral retainer-like device that works as a receiver. The intraoral system purportedly functions similar to a bone conduction hearing aid and is indicated for adults with single sided deafness. (Refer to Coverage Limitations section)

Semi-Implantable Middle Ear Hearing Aid

A semi-implantable middle ear hearing aid involves a procedure where a magnetic implant coil is wrapped around the ossicles behind the eardrum via a small incision. Electromagnetic energy then vibrates the implant which directly stimulates the inner ear or cochlea. Examples of semi-implantable middle ear hearing aids include, but may not be limited to, Maxum Hearing Implant System or the Vibrant SOUNDBRIDGE System.

Coverage Determination

Any state mandates for cochlear implants and hearing aids take precedence over this medical coverage policy.

Auditory Brainstem Implants

Implantable hearing devices, including auditory brainstem implants may be excluded by certificate. Please consult the member's individual certificate regarding Plan coverage.

If implantable hearing devices are not excluded by certificate, the following criteria applies.

Humana members may be eligible under the Plan for an FDA-approved auditory brainstem implant (eg, Nucleus Profile Plus Auditory Brainstem Implant), when the following criteria are met:

• 12 years of age or older; AND
• Diagnosed with neurofibromatosis type 2 (NF2); AND
• Bilateral surgical removal of auditory nerve tumors is planned and is expected to result in complete bilateral deafness or surgery has occurred and has resulted in complete bilateral deafness; AND

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• Documentation from the physician attesting that the individual and/or family is highly motivated to participate in the postoperative programming/rehabilitation process and has realistic expectations

Humana members may be eligible under the Plan for replacement/upgrade of auditory brainstem implants and/or its external components when the following criteria are met:

• Existing device malfunctions or cannot be repaired; OR
• Replacement is required due to a change in the individual’s condition that makes the present unit nonfunctional

Bone Anchored/Bone Conduction Hearing Aids

Implantable hearing devices (eg, bone anchored/bone conduction hearing aids, semi-implantable middle ear hearing aids) may be excluded by certificate. Please consult the member’s individual certificate regarding Plan coverage.

If implantable hearing devices are not excluded by certificate, the following criteria applies.

Humana members may be eligible under the Plan for a percutaneous bone anchored hearing aid (pBAHA) or transcutaneous bone anchored hearing aid (tBAHA) when the following criteria are met:

• Assessment of hearing impairment has been completed by an audiologist to determine implant candidacy; AND
• Bone anchored/bone conduction hearing aid must be utilized in accordance with FDA-approved indications for the device, including age (see Table 1); AND
• Use of a conventional hearing aid is precluded by one of the following:
• Congenital or acquired malformation of the middle/external ear (eg, congenital aural atresia, microtia, small ear canals, tumor); OR
• Severe chronic otitis media

Table 1 FDA-Approved Bone Anchored/Bone Conduction Hearing Aids and Indications

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Humana members may be eligible under the Plan for replacement/upgrade of a bone anchored/bone conduction hearing aid and/or its external components when the following criteria are met:

• Existing device malfunctions or cannot be repaired; OR
• Replacement is required due to a change in the individual’s condition that makes the present unit nonfunctional

Cochlear Implants

Humana members may be eligible under the Plan for a unilateral or bilateral cochlear implant when the following criteria are met:

• Absence of contraindications; AND
• Assessment of hearing impairment has been completed by an audiologist to determine implant candidacy; AND
• Current on age appropriate pneumococcal vaccination (2 or more weeks before surgery when possible) in accordance with Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP)15,16; AND
• Documentation from the physician attesting that the individual and/or family is highly motivated and willing to participate in the postoperative programming/rehabilitation process and has realistic expectations; AND
• Implant must be utilized in accordance with FDA-approved indications for the device, including age (see Table 2)

Table 2 FDA-Approved Cochlear Implants and Indications

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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• Bilateral, pre-, peri- or post-linguistic sensorineural hearing impairment of moderate-to-profound hearing loss in the low frequencies and profound hearing loss defined as greater than or equal to 90 dB HL in the mid to high speech frequencies; AND

• Limited benefit from appropriate binaural hearing aids, as defined by test scores of 50% correct or less in the ear to be implanted (60% or less in the best aided listening condition) on tape recorded tests of open set sentence recognition

Children • Children 9 to 24 months of age who have bilateral profound sensorineural deafness OR children 2 years of age or older who demonstrate severe-to-profound hearing loss bilaterally; AND

• Limited benefit from appropriate binaural hearing aids, which is defined as:

• In younger children, lack of progress in the development of simple auditory skills in conjunction with appropriate amplification and participation in intensive aural habilitation over a three to six month period. It is recommended that limited benefit be quantified on a measure such as the MAIS or the ESP test; OR
• In older children, limited benefit from a 3 to 6 month trial of hearing aids, as defined by test scores less than or equal to 30% correct on the open set MLNT or LNT, depending upon the child’s cognitive and linguistic skills

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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Humana members with a unilateral cochlear implant for bilateral severe to profound sensorineural hearing loss may be eligible under the Plan for subsequent contralateral implantation.

Humana members may be eligible under the Plan for replacement/upgrade of a cochlear implant and/or its external components when the following criteria are met:

• Existing device malfunctions or cannot be repaired; OR
• Replacement is required due to a change in the individual's condition that makes the present unit nonfunctional

Note: The criteria for cochlear implants are not consistent with the Medicare National Coverage Policy and therefore may not be applicable to Medicare members. Refer to the CMS website for additional information.

Semi-Implantable Middle Ear Hearing Aid

Implantable hearing devices (eg, bone anchored/bone conduction hearing aids, semi-implantable middle ear hearing aid) may be excluded by certificate. Please consult the member's individual certificate regarding Plan coverage.

If implantable hearing devices are not excluded by certificate, the following criteria applies.

Humana members may be eligible under the Plan for an FDA-approved semi- implantable middle ear hearing aid (eg, Maxum Hearing Implant, Vibrant SOUNDBRIDGE system)78,79 when the following criteria are met:

• 18 years of age or older; AND
• Absence of contraindications; AND
• Assessment of hearing impairment has been completed by an audiologist to determine implant candidacy; AND
• Moderate-to-severe SNHL (no conductive hearing loss present); AND

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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• Use of a conventional hearing aid is precluded by one of the following:
• Congenital or acquired malformation of the middle/external ear (eg, congenital aural atresia, microtia, small ear canals, tumor); OR
• Severe chronic otitis media

Humana members may be eligible under the Plan for replacement/upgrade of a semi-implantable middle ear hearing aid and/or its external components when the following criteria are met:

• Existing device malfunctions or cannot be repaired; OR
• Replacement is required due to a change in the individual’s condition that makes the present unit nonfunctional

Coverage Limitations

Auditory Brainstem Implants

Humana members may NOT be eligible under the Plan for an auditory brainstem implant (eg, Nucleus Profile Plus Auditory Brainstem Implant) for any indications other than those listed above. All other indications are considered not medically necessary as defined in the member’s individual certificate. Please refer to the member’s individual certificate for the specific definition.

Bone Anchored/Bone Conduction Hearing Aids

Humana members may NOT be eligible under the Plan for the following bone anchored/bone conduction hearing aids (eg, Baha [Connect] System, Ponto Bone Anchored Hearing System, Alpha 2 MPO ePlus, Baha [Attract] System, BONEBRIDGE, Osia System) for any indications other than those listed above. All other indications are considered experimental/investigational as they are not identified as widely used and generally accepted for any other proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Cochlear Implants

Humana members may NOT be eligible under the Plan for cochlear implants (eg, HiRes Ultra, HiRes Ultra 3D, Neuro Cochlear Implant System, Nucleus Profile Plus, SYNCHRONY 2 Cochlear Implant) for any indications other than those listed above OR if any of the following contraindications74 are present:

• Absence of auditory nerve or cochlear development (eg, cochlear aplasia); OR
• Active inner or middle ear infections; OR
• Deafness due to lesions of the acoustic nerve or central auditory pathway; OR
• Dysfunction of the acoustic nerve; OR
• Tympanic membrane perforation in the presence of active middle ear disease

All other indications are considered experimental/investigational as they are not identified as widely used and generally accepted for any other proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Humana members may NOT be eligible under the Plan for cochlear implants for unilateral sensorineural hearing loss or asymmetric hearing loss, as they may be excluded by certificate. Please consult the member’s individual certificate regarding Plan coverage. If not excluded by certificate, these are considered not medically necessary as defined in the member’s individual certificate.

Humana members may NOT be eligible under the Plan for a cochlear implant for auditory neuropathy spectrum disorder/auditory neuropathy.

This is considered experimental/investigational as it is not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

Humana members may NOT be eligible under the Plan for assistive listening devices used alone or with a cochlear implant, as they are considered hearing aids and may be excluded by certificate. Please consult the member’s individual certificate regarding Plan coverage. If not excluded by certificate, these are considered not medically necessary as defined in the member’s individual certificate.

Hybrid Cochlear Implant System

Humana members may NOT be eligible under the Plan for a hybrid cochlear implant system (eg, Nucleus Hybrid Implant System). This is considered experimental/investigational as it is not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

Implantable and Non-Implantable Hearing Devices Effective Date: 02/02/2023
Revision Date: 02/02/2023
Review Date: 02/02/2023
Policy Number: HUM-0377-029
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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

Fully Implantable Middle Ear Hearing System

Humana members may NOT be eligible under the Plan for fully implantable middle ear hearing systems (eg, Esteem Implant) as they may be excluded by certificate. If not excluded by certificate, these are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Nonimplanted Hearing Devices

Humana members may NOT be eligible under the Plan for nonimplanted bone conduction devices including, but may not be limited to:

• ADHEAR
• Baha Softband
• Baha SoundArc
• Ponto Softband 5

These devices may be excluded by certificate. If not excluded by certificate, these are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Humana members may NOT be eligible under the Plan for an intraoral bone conduction hearing device. This is considered experimental/investigational as it is not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

Semi-Implantable Middle Ear Hearing Aid

Humana members may NOT be eligible under the Plan for a semi-implantable middle ear hearing aid (eg, Maxum Hearing Implant, Vibrant SOUNDBRIDGE System) for any indications other than those listed above OR if any of the following contraindications59,78,79 are present:

Implantable and Non-Implantable Hearing Devices Effective Date: 02/02/2023
Revision Date: 02/02/2023
Review Date: 02/02/2023
Policy Number: HUM-0377-029
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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.

Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

• Absent or nonfunctioning auditory nerve pathway (applicable only to Vibrant SOUNDBRIDGE System); OR
• Active middle ear infection; OR
• Conductive hearing loss; OR
• Disabling tinnitus (applicable only to Maxum Hearing Implant); OR
• Recurrent middle ear infections; OR
• Retrocochlear or central auditory disorder; OR
• Tympanic membrane perforations associated with recurrent middle ear infections

All other indications are considered experimental/investigational as they are not identified as widely used and generally accepted for any other proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.

Additional information about hearing loss, sensorineural hearing loss or neurofibromatosis type 2 may be found from the following websites:

Background

• American Academy of Otolaryngology – Head and Neck Surgery
• American Speech-Language-Hearing Association
• National Library of Medicine

Medical Alternatives

Physician consultation is advised to make an informed decision based on an individual’s health needs.

Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific