Oscar Hearing Aids (CG001) Form

The Plan Members with Hearing Impairments

Plan members who have a hearing impairment may be eligible for a hearing aid depending on their plan. Hearing aids are amplifying devices designed to help compensate for hearing loss, and come in several different types. These include devices outside the ear or in the ear canal that bring sound more effectively into the eardrum; devices that attach to bones in the ear to help transmit sound through vibration; and special devices that can be implanted in the ear or skull that help sound travel through the ear and reach the brain.

Certain hearing aids are not appropriate for all types of hearing impairment, and special hearing tests should be done to determine the degree of hearing loss and see if a device may be helpful. The device must be prescribed by a licensed physician or audiologist.

Definitions

• Air-Conduction (Standard Wearable) Hearing Aids include devices that are placed outside the ear or in the external ear canal which help amplify sound through the ear canal to the eardrum.
• Bone-Anchored Hearing Aids are surgically implanted prosthetic devices, which transmit sound through bone to the inner ear, bypassing the external auditory canal and middle ear.
• Cochlear Implants are surgically implanted, electronic medical devices, that do the work of damaged parts of the inner ear and provide sound signals to the brain. They require an intact auditory nerve to transmit signals to the brainstem.
• Hybrid Cochlear Implants are used in individuals with some preserved low frequency hearing. These function by combining a partial cochlear implant with an external hearing aid.
• Auditory Brainstem Implants (ABI) are surgically implanted devices that stimulate the brainstem directly in response to external sounds. These devices are used most often for individuals with loss of function of the auditory nerve that transmits sound information from the cochlea to the brainstem.

Clinical Indications

Air-Conduction (Standard Wearable) Hearing Aids

Please see the member's plan benefits

The Plan considers air-conduction (AC) hearing aids from a network hearing aid provider medically necessary when ALL of the following criteria are met:

1. A prescription or medical clearance from a licensed provider, with documentation that hearing loss has been medically evaluated AND documentation of a plan for hearing aid test and fitting with a licensed audiologist. Furthermore, a statement that the member is able to utilize the device properly; and
2. At least ONE of the following:
   • Sensorineural hearing loss at a threshold of greater than 30 dB HL at any two frequencies of 500, 1,000, 2,000, 3,000, and 4,000 Hz in the ear(s) to be aided for adult members; or
   • Pure tone average sensorineural threshold measured at frequencies of 500, 1,000, 2,000, 3,000, and 4,000 Hz greater than or equal to 26 dB HL in the ear(s) to be aided for adult members; or
   • Sensorineural hearing loss at a threshold of 25 dB HL or greater at frequency of at least 500 Hz in the ear(s) to be aided for members under the age of majority. Furthermore, a medical clearance must be obtained from a health care provider within 6 months to hearing aid fitting.

Bone-Anchored Hearing Aids

Please see the member's plan benefits

The Plan considers bone-anchored hearing aids (BAHA) provided by a network hearing aid provider medically necessary when ALL of the following criteria are met:

1. The member is age 5 years or older; and
   • Note: Children under the age of 5 may be eligible for a soft headband with a partially or fully-implanted transcutaneous bone conduction hearing aid when other criteria are met.
2. Hearing loss is unilateral or bilateral; and
3. Hearing loss is either of the following:
   • Conductive or mixed (both conductive and sensorineural) without improvement after medical or surgical interventions; or
   • Unilateral pure sensorineural;
4. Use of conventional AC hearing aids have failed or are not appropriate due to:
   • Congenital or surgically induced malformations (e.g., atresia) of the external ear canal or middle ear; or
   • Chronic external otitis or otitis media; or
   • Tumors of the external canal and/or tympanic cavity; or
   • Dermatitis of the external canal; or
   • Other conditions for which an AC hearing aid is contraindicated; and
5. Pure tone average bone conduction hearing threshold measured at 500, 1,000, 2,000, and 3,000 Hz less than or equal to level appropriate for model to be implanted in the affected ear(s) such as thresholds of 45, 55, or 65 dB HL depending on model of device. The requested device must be FDA approved; and
6. If a bilateral implant is requested, members should meet the above audiologic criteria, the device must be FDA approved, and have symmetrically conductive or mixed hearing loss as defined by:
   • 10 dB average difference between ears measured at 500, 1,000, 2,000, 3,000 and/or 4,000 Hz, or less than a 15 dB difference at individual frequencies; and
7. A prescription or medical clearance from a licensed provider with documentation that hearing loss has been medically evaluated AND documentation of a plan for hearing aid testing and fitting with a licensed audiologist. Furthermore, a statement that the member is able to utilize the device properly.

Cochlear Implants

(For hybrid cochlear implants, please see the section below)

Please see the member's plan benefits

The Plan considers cochlear implants medically necessary when the device is FDA approved and ALL of the following criteria are met:

Severe to Profound Bilateral Sensorineural Hearing Loss (for asymmetric or single-sided deafness please see criteria below):

For children up to 18 years (ALL of the following):

1. Severe to profound bilateral sensorineural hearing loss as measured by the unaided pure-tone average threshold that is greater than or equal to 70 dB (severe) (e.g., measured at 500, 1,000, 2,000 Hz, etc. ); and
2. b.

1. For severe to profound bilateral sensorineural hearing loss, a 1-month hearing aid trial has been undertaken by the child without previous experience with hearing aids with limited benefit as defined by failure to achieve developmentally appropriate auditory milestones on a validated, age appropriate measure; and
   • Note: Members with complete or total hearing loss (95 dB or greater) do not require a hearing aid trial.
2. No medical contraindications to cochlear implantation exist, as documented on MRI or CT scan when applicable, including but not limited to:
   • Dysfunctional acoustic nerve; or
   • Cochlear aplasia; or
   • Complete labyrinthine aplasia; or
   • Absent cochlear nerve; or
   • Central auditory dysfunction (e.g. cortical deafness); or
   • Tympanic membrane perforation; or
   • Active inner or middle ear infection; and
3. Family support and motivation to participate in post-implant rehabilitation.

2. For adults aged 18 years and older, the initial unilateral cochlear implant (ALL of the following):
   • Severe or profound bilateral sensorineural hearing loss as measured by the pure-tone average threshold that is greater than or equal to 70 dB (measured at 500, 1,000, 2,000 Hz, etc. ); and
   • Limited benefit from binaural hearing aids as defined by "open-set sentence recognition" (e.g., HINT) of 50% or less in the best-aided condition; and
   • No medical contraindications to cochlear implantation exist, as documented on MRI or CT scan when applicable, including but not limited to:
     • Dysfunctional acoustic nerve; or
     • Cochlear aplasia; or
     • Complete labyrinthine aplasia; or
     • Absent cochlear nerve; or
     • Acoustic nerve lesion; or
     • Central auditory dysfunction (e.g., cortical deafness); or
     • Tympanic membrane perforation; or
     • Active inner or middle ear infection; and
   • Member is motivated to participate in post-implant rehabilitation; or
3. For adults aged 18 years and older, the second (sequential) cochlear implant (ALL of the following):
   • Original implant on the opposite side is functioning successfully; and
   • Medical contraindication criteria in “2C” are ruled out for the unimplanted side; and
   • There continues to be zero or a minimal benefit from a hearing aid in the unimplanted ear; and

4. For all members, a prescription or medical clearance from a licensed provider with documentation that hearing loss has been medically evaluated AND documentation of a plan for implant testing and fitting with a licensed audiologist. Furthermore, a statement that the member is motivated to participate in post-implant rehabilitation.

Asymmetric Sensorineural Hearing Loss, or Severe to Profound Single-Sided Deafness (SSD)/Unilateral Sensorineural Hearing Loss

(Please see the member’s plan benefits):

The Plan considers cochlear implants medically necessary when the device is FDA approved for the age range and ALL of the following criteria are met:

1. The member meets one of the diagnosis:
   • Asymmetric sensorineural hearing loss, as defined by hearing loss in both ears (threshold of 20.0 dB or greater) but level of loss is different in each ear by 15dB; or
   • Unilateral Sensorineural Hearing Loss, Single-Sided Deafness (SSD) as defined by when one ear hearing normal (threshold < 20.0 dB), but the other ear has severe, profound, to complete hearing loss with a threshold greater than or equal to 70 dB; and
2. The member conducts a hearing aid trial:
   • For children, at least 1-month hearing aid trial has been undertaken without previous experience with a hearing aid in the ear to be implanted with limited benefit as defined by failure to achieve developmentally appropriate auditory milestones on a validated, age appropriate measure; or
   • For adults 18 years or older, at least 1-month hearing aid trial has been undertaken and limited benefit from hearing aid in the ear to be implanted as defined by "open-set sentence recognition" (e.g., HINT) of 50% or less in the best-aided condition; and
3. No medical contraindications to the cochlear implantation exist:
   • Acoustic nerve lesion; or
   • Dysfunctional acoustic nerve; or
   • Cochlear aplasia; or
   • Complete labyrinthine aplasia; or
   • Absent cochlear nerve; or
   • Central auditory dysfunction (e.g., cortical deafness); or
   • Tympanic membrane perforation; or
   • Active inner or middle ear infection.

Hybrid Cochlear Implants

Depending on your individual plan, the Plan considers hybrid cochlear implants medically necessary only when ALL of the following criteria are met:

1. The member is age 18 years or older; and
2. Severe or profound bilateral sensorineural hearing loss of high-frequency sounds in both ears, but can still hear low-frequency sounds with or without a hearing aid; and
3. ALL of the following hearing thresholds are met:
   • Low frequency hearing thresholds of no worse than 60 dB up to and including 500 Hz (averaged over 125, 250, and 500 Hz) in the ear selected for implantation; and
   • Severe to profound mid-to-high frequency hearing loss (threshold average of greater than or equal to 75 dB measured at 2000, 3000, and 4000 Hz) in the ear to be implanted; and
   • Moderately severe to profound mid-to-high frequency hearing loss (threshold average greater than or equal to 60 dB measured at 2000, 3000, and 4000 Hz) in the contralateral ear; and
   • Aided consonant-nucleus-consonant word recognition score from 0% to 60% in the ear to be implanted in the preoperative aided condition; and
   • Aided consonant-nucleus-consonant word recognition score in the contralateral ear will be equal to or better than that of the ear to be implanted but less than 80% correct.
4. Limited benefit from trial of binaural hearing aids; and
5. No medical contraindications to the cochlear implantation exist:
   • Acoustic nerve lesion; or
   • Dysfunctional acoustic nerve; or
   • Cochlear aplasia; or
   • Complete labyrinthine aplasia; or
   • Absent cochlear nerve; or
   • Central auditory dysfunction (e.g., cortical deafness); or
   • Tympanic membrane perforation; or
   • Active inner or middle ear infection; and

Auditory Brainstem Implant (ABI)

The Plan considers auditory brainstem implants (ABI) medically necessary when ALL of the following criteria are met:

1. Member is 12 years of age or older; and
2. Diagnosis of neurofibromatosis type 2 with ANY of the following:
   • At least 70 dB hearing loss due to bilateral functional loss of the auditory nerves; or
   • Planned surgery that is reasonably expected to result in bilateral loss of function of the auditory nerves and complete deafness, where the implant will be placed at the time of surgery; and
3. Limited benefit from trial of binaural hearing aids (in cases of an intact auditory nerve(s)); and
4. A prescription or medical clearance from a licensed provider with documentation that hearing loss has been medically evaluated AND documentation of a plan for implant testing and fitting with a licensed audiologist. Furthermore, a statement that the member is motivated to participate in post-implant rehabilitation.

Additional Medically Necessary Services include:

• Comprehensive hearing assessment; or
• Charges for associated fitting and testing; or
• Applicable dispensing fees; or
• Ear molds and 1 headband per year for bone-anchored hearing implants or bone-conduction hearing aids, if applicable; or
• Replacement external processors for cochlear implants, once the warranty has expired.

Experimental or Investigational / Not Medically Necessary

The Plan considers the following alternative listening devices [e.g., advanced hearable devices, smartphone/wireless products, and non-conventional hearing devices, Personal Sound Amplification Products (PSAPs)] not medically necessary.

The Plan considers the use of BAHA for bilateral pure sensorineural hearing loss experimental and investigational.

Devices that are considered experimental or investigational, such as:

• Free-floating piezoelectric microphone
• Implantable and semi-implantable hearing aids of the middle ear

Rationale: There is limited evidence on the effectiveness and safety of middle ear implants. A meta-analysis found zero randomized studies, and that the general quality of the existing studies was poor and with short-term follow-up. Other meta-analyses have largely reflected these findings and the general consensus has been that further long-term data is required.

• Intra-oral bone conduction hearing aids (e.g., SoundBite Hearing System)

The Plan considers the following auditory brainstem implants (ABI) experimental and investigational:

• Penetrating electrode auditory brainstem implants (PABI)

Rationale: The evidence for PABI is limited to single institution retrospective experiences and there have been no established data comparing this technique to traditional ABI. Furthermore, this approach has not yet been FDA approved, limiting application to clinical trial study.

• ABI in children under the age of 12 years old

Rationale: ABI has not yet been fully evaluated in children under the age of 12, and at the present time is not FDA approved in that population. There are open clinical trials looking at the use of ABI in this population, however the current data is limited in that it is retrospective or in small case-studies.

• Bilateral use of an auditory brainstem implant.

Rationale: The evidence for bilateral use of auditory brainstem implant is limited. Additional research is needed to demonstrate improvement with second auditory brainstem implants.