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

Advanced Bionics

Status: Completed

Conditions: Hearing Disorders; Otorhinolaryngologic Diseases; Ear Diseases; Hearing Loss; Asymmetrical Hearing Loss; Single-Sided Deafness

Treatments: Device: HiResolution Bionic Cochlear Implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT02811549

CR0314

Details and patient eligibility

About

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).

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

HiResolution Bionic Cochlear Implant

Experimental group

Description:

HiRes 90K™ Advantage implant with HiFocus™ 1J electrode, HiRes 90K™ Advantage implant with the HiFocus Helix™ electrode, HiRes 90K™ Advantage implant with the HiFocus™ Mid-Scala electrode or the HiRes™ Ultra Implant with the HiFocus™ Mid-Scala electrode will be implanted 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).

Treatment:

Device: HiResolution Bionic Cochlear Implant