Clinical Evaluation of a Cochlear Implant Sound Processor

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-17

Study Completion Date

2020-10-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of Remote Fitting in Adult and Pediatric Users of the HiResolution Bionic Ear System

NCT05034731

Hearing Loss Ear Diseases Hearing Disorders +1 more

COMPLETED

Evaluation of Remote Programming of Cochlear Implants in Routine Cochlear Implant Follow-up

NCT06894303

Cochlear Hearing Loss

RECRUITING

ClearVoice Sound-processing Strategy for AB HiRes 120 Cochlear Implant Users

NCT01066780

Implant

COMPLETED NA

Investigating Auditory Processing in the Users of Auditory Brainstem and Cochlear Implants

NCT05810220

Deafness

RECRUITING NA

Comparing the Performance of a Categorical Loudness Scaling Based Fitting With a Behavioural Fitting in Adults With a Nucleus Cochlear Implant 3 Months Post-activation

NCT05709223

Hearing Loss

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hearing Loss Ear Diseases Hearing Disorders Otorhinolaryngologic Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Aidable Residual Hearing (ARH) Cohort

Control Device followed by experimental Device.

Group Type OTHER

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

Intervention Type DEVICE

Control cochlear implant sound processor

301-M062 sound processor & software

Intervention Type DEVICE

New cochlear implant sound processor

Electric Only (EO) Cohort

Control Device followed by experimental Device.

Group Type OTHER

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

Intervention Type DEVICE

Control cochlear implant sound processor

301-M062 sound processor & software

Intervention Type DEVICE

New cochlear implant sound processor

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Control cochlear implant sound processor

Intervention Type DEVICE

301-M062 sound processor & software

New cochlear implant sound processor

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

* 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

• 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No