This document addresses cochlear implants, auditory brainstem implants, and replacement or upgrade of speech processor and controller components. This document does not address replacement parts other than as specifically described below.

A single- or multi-channel unilateral or bilateral cochlear implant is intended to restore a level of auditory sensation to an individual with bilateral severe to profound sensorineural hearing loss by means of electrical stimulation of the auditory nerve. A unilateral hybrid cochlear implant is intended to restore a level of auditory sensation to an individual with residual low-frequency hearing sensitivity and bilateral severe to profound sensorineural hearing loss.

An auditory brainstem implant is a device designed to restore some hearing in an individual with neurofibromatosis type 2 (NF-2) who has been rendered deaf by the surgical removal of neurofibromas involving both auditory nerves.

Clinical Indications

I. Cochlear Implants

Medically Necessary:

1. Cochlear implantation is considered medically necessary when both criterion 1 and criterion 2 listed below are met:
   1. The individual meets All the following criteria (a through c):
      1. Has received limited benefit from conventional hearing aids; and
      2. Is able to participate* in a post-cochlear implant rehabilitation program; and
      3. Absence of any of the following (i through iv):
         1. Active middle ear infections; or
         2. Lesions in the auditory nerve; or
         3. Lesions in the central auditory pathway; or
         4. Auditory neuropathy spectrum disorders.
            *Note: For a young child, a parent or guardian may act as the surrogate for participation.
            and
   2. The individual has unilateral or bilateral sensorineural deafness with hearing loss in the ear(s) to be implanted greater than or equal to 70 dB.
      (Implantation may be unilateral, bilateral-simultaneous [same session] procedures, or bilateral-sequential [different session] procedures. If bilateral-sequential, hearing tests do not need to be repeated between procedures.)
2. Upgrade to or replacement of an existing external speech processor, controller or speech processor and controller (integrated system) is considered medically necessary when the following criteria (1 and 2) are met:
   1. The existing components no longer meet the individual’s needs as demonstrated by one of the following:
      1. Functional but inadequate to the point of interfering with the activities of daily living; or
      2. No longer functional;
         and
   2. The request is NOT for convenience or to upgrade to a newer technology when the current components remain functional.
3. Unilateral implantation of a hybrid cochlear implant device (for example, Nucleus^® Hybrid^™ L24 Cochlear Implant System) is considered medically necessary when all of the following criteria are met (1, 2, and 3 are required):
   1. Hearing requirements for the ear to be implanted (both a and b required):
      1. Hearing loss is 60 dB or lower at 125, 250, and 500 Hz; and
      2. Hearing loss is 75 dB or greater at 2000, 3000, and 4000 Hz; and
   2. Hearing loss in the contralateral (non-implanted) ear is 60 dB or greater at 2000, 3000, and 4000 Hz;
      and
   3. Preoperative Consonant-Nucleus-Consonant (CNC) word recognition (speech perception) scores show both of the following (both a and b required):
      1. Ear to be implanted CNC score is between 10% and 60%; and
      2. Contralateral (non-implanted) ear CNC score shows both of the following criteria (i and ii required):
         1. CNC score is 80% or lower in the best-aided condition; and
         2. CNC score is higher than the ear to be implanted.

Not Medically Necessary:

1. Upgrade to or replacement of an existing external speech processor, controller or speech processor and controller (integrated system) is considered not medically necessary when the criteria specified above are not met.
2. A cochlear implant is considered not medically necessary for all other indications when the above criteria are not met, including as a treatment of tinnitus in the absence of severe hearing loss (greater than or equal to 70 dB).

II. Auditory Brainstem Implants

Medically Necessary:

1. An auditory brainstem implant is considered medically necessary in an individual when all of the following criteria are met: 
   1. Is 12 years of age or older; and
   2. Diagnosed with neurofibromatosis type 2; and
   3. Is completely deaf as a result of bilateral neurofibromas of the auditory nerve.
2. Upgrade to or replacement of an existing external sound processor, remote assistant or both components is considered medically necessary for an individual whose response to existing components is inadequate to the point of interfering with the activities of daily living or when components are no longer functional.

Not Medically Necessary:

1. Upgrade to or replacement of an existing external sound processor, remote assistant, or both components is considered not medically necessary when the criteria specified above are not met; including as a treatment for tinnitus in the absence of severe hearing loss.
2. An auditory brainstem implant is considered not medically necessary for all other indications when the above criteria are not met.