Clinical Evaluation of a Cochlear Implant Sound Processor

Advanced Bionics

Status

Completed

Conditions

Hearing Disorders

Otorhinolaryngologic Diseases

Ear Diseases

Hearing Loss

Treatments

Device: 301-M062 sound processor & software

Device: Naída Cochlear Implant Q90 sound processor (Naida CI Q90) & software

Study type

Interventional

Funder types

Industry

Identifiers

NCT04237207

CR1218

Details and patient eligibility

About

This is a prospective within-subjects repeated-measures study that will enroll 24 adult users implanted with a HiResolution Bionic Ear System (HiRes 90K or newer). Subjects will be assigned to one of two cohorts based on audiometric results at the Baseline visit

Full description

The overall goal of this clinical study is to demonstrate the safety and efficacy of a cochlear implant sound processor. Hearing outcomes are expected to be similar non-inferior to as compared to the currently approved software and processors. Therefore, the study described herein uses a non-inferiority design to determine whether sentence recognition in quiet and in noise is no worse with the new sound processor than with currently approved software on a Q90 processor.

Enrollment

22 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

General Inclusion Criteria:

Ability to provide Informed Consent
18 years of age or older
Unilateral user of a HiResolutionTM Bionic Ear System (HiRes 90KTM, HiRes 90KTM Advantage, HiResTM Ultra, HiResTM Ultra 3D), including bilaterally implanted subjects that only use one implant in their everyday listening modality
Minimum of 6 months of CI experience
Having used a Naída CI Q70 or a Naída CI Q90 as their primary processor for a minimum of one month
Presently using a current steering strategy
At least moderate open-set speech recognition abilities with implant alone, as defined by achieving a score of ≥ 60% words correct in the AzBio in quiet test using the Naída CI Q90 research processor
English language proficiency as determined by the investigator
Willingness to use a BTE processor for the duration of the study

ARH Arm Inclusion Criteria

Residual low frequency hearing sensitivity (pure tone average of < 70 dB HL for 125, 250, and 500 Hz) and a severe-to-profound high-frequency sensorineural hearing loss (pure tone average of ≥ 70 dB HL for 1,000, 2,000, 3000, 4,000, and 8,000 Hz) in the implanted ear
Willingness to use an in-canal acoustic earhook for the duration of the study

EO Arm Inclusion Criteria

• Severe-to-profound sensorineural hearing loss in the low (pure tone average of ≥ 70 dB HL for 125, 250, and 500 Hz) and high frequencies (pure tone average ≥ 70 dB HL for 1,000, 2,000, 3000, 4,000, and 8,000 Hz) in the implanted ear

Exclusion Criteria:

Unrealistic expectations regarding potential benefits, risks and limitations of the investigational device as determined by the investigator
Unwillingness or physical / cognitive inability of subject to comply with all investigational requirements as determined by the investigator