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

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

The purpose of this feasibility study is to evaluate the benefit of unilateral implantation in adults who have severe to profound sensorineural hearing loss in one ear, and up to moderate sensorineural hearing loss in the other ear (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