Benefits of the HiResolution Bionic Ear System in Adults With Asymmetric Hearing Loss

Inclusion Criteria:

General Requirements:

- Ability to provide Informed Consent

- 18 years of age or older

- English language proficiency

- Willingness to participate in all scheduled procedures outlined in the study
investigational plan

- Willingness to use an approved cochlear implant signal processing strategy in an
everyday listening program during study

Ear to be Implanted:

- Severe-to-profound sensorineural hearing loss (> 70 dB HL) as defined by the pure tone
average for 500, 1000, 2000 and 4000 Hz

- CNC word recognition score ≤30% (tested in subject's everyday listening condition for
that ear)

- Duration of severe-to-profound sensorineural hearing loss (≥ 70 dB HL) >3 months and
≤10 years in the ear to be implanted only

Contralateral (non-implanted) ear:

- Up to a moderate sensorineural hearing loss (<70 dB HL) as defined by the pure tone
average for 500, 1000, 2000 and 4000 Hz

- CNC word recognition score >30% (tested in subject's everyday listening condition for
that ear)

Exclusion Criteria:

- Previous experience with a cochlear implant

- Cochlear malformation or obstruction (i.e. ossification) that would preclude full
insertion of electrode array in the ear to be implanted

- Medical or psychological conditions that contraindicate surgery or impact the ability
to manage an implanted device or the study related procedures as determined by the
investigator

- Diagnosis of auditory neuropathy/dys-synchrony in either the ear to be implanted or
the contralateral ear

- Active middle-ear disease/infection in the ear to be implanted

- Unrealistic expectations regarding potential benefits, risks and limitations inherent
to implant surgical procedures as determined by the investigator

- Unwillingness or inability of subject to comply with all investigational requirements
as determined by the investigator