Evaluation of Hearing Preservation in Adults With Partial Low-Frequency Hearing Implanted With the HiFocus™ Mid-Scala Electrode

Advanced Bionics

Status: Terminated

Conditions: Hearing Disorders; Otorhinolaryngologic Diseases; Ear Diseases; Hearing Loss; Deafness

Treatments: Device: HiRes™ 90K Advantage implant with HiFocus™ Mid-Scala electrode

Study type: Interventional

Funder types: Industry

Identifiers

NCT01959152

CR0513

Details and patient eligibility

About

The purpose of this study is to determine the feasibility of preserving low-frequency acoustic hearing in adults with a moderate degree of hearing loss in the low frequencies and severe-to-profound hearing loss in the mid-to-high frequencies who are implanted with the HiRes™ 90K Advantage implant with HiFocus™ Mid-Scala electrode.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• No previous cochlear implant experience
• 18 years of age or older
• Up to a moderate sensorineural hearing loss in the low-to-mid frequencies (pure tone average ≤ 65 dB HL for 125, 250, 500, and 1000 Hz) and a severe-to-profound sensorineural hearing loss in the high frequencies (pure tone average ≥ 70 dB HL for 2,000, 4,000, and 8,000 Hz) in the ear to be implanted
• Aided monosyllabic word score of 10-50% in the ear to be implanted
• Up to a moderate sensorineural hearing loss in the low-to-mid frequencies (pure tone average ≤ 65 dB HL for 125, 250, 500, and 1000 Hz) and a severe-to-profound sensorineural hearing loss in the high frequencies (pure tone average ≥ 70 dB HL for 2,000, 4,000, and 8,000 Hz) in the contralateral (non-implanted) ear
• English language proficiency
• Willingness to participate in all scheduled procedures outlined in the protocol

Exclusion criteria

• Previous inner ear surgery
• Cochlear malformation or obstruction that would preclude full insertion of electrode array
• Presence of additional disabilities that would prevent or interfere with participation in the required study procedures
• Medical or psychological conditions that contraindicate surgery or impact the ability to manage an implanted device or the study-related procedures
• Evidence of central auditory lesion or compromised auditory nerve

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

HiRes90K™ Advantage Cochlear Implant

Experimental group

Description:

HiRes90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be implanted in adults with a moderate level of hearing loss in the low frequencies and severe-to-profound hearing loss in the mid-to-high frequencies.

Treatment:

Device: HiRes™ 90K Advantage implant with HiFocus™ Mid-Scala electrode