Evaluation of Remote Fitting in Adult a… | Clinical Trial

Key information

Conditions

Hearing Loss Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otolaryngological Disease Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Primary location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

About this study

The overall goal of this clinical study is to demonstrate the safety and efficacy of the remote fitting option. Hearing outcomes are expected to be similar whether a study subject's sound processor is programmed in the traditional method in the audiologist's office or whether programming is performed via remote fitting. Therefore, the study described herein uses a non-inferiority design to determine whether sentence recognition in quiet is no worse with remote fitting than in an in-office setting.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All Subjects

Ability to provide Informed Consent/Assent
13 years of age or older
Unilateral or bilateral user of a HiResolutionTM Bionic Ear System (HiRes 90KTM, HiRes 90KTM Advantage, HiResTM Ultra, HiResTM Ultra 3D)
Minimum of 6 months of CI experience with a minimum of 1 month experience with a Naída CI or Sky CI sound processor
At least moderate open-set speech recognition abilities (defined as speech in quiet score ≥ 60% as assessed at Visit 1)
Minimum average score ≥ 3 on the Mobile Device Proficiency Questionnaire (MDPQ-16)
English language proficiency as determined by the Investigator
Willingness to use a BTE sound processor for the duration of the study

Inclusion criteria

Specific to Aidable Residual Hearing Group

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 for unilaterally implanted subjects and in both ears for bilaterally implanted subjects
Willingness to use an in-canal acoustic earhook for the duration of the study

Exclusion criteria

Clinical presentation indicative of potential implanted device malfunction
Unrealistic expectations regarding potential benefits, risks and limitations of the investigational device as determined by the Investigator
Unwillingness or inability of subject to comply with all investigational requirements as determined by the Investigator

Treatment and study plan

Remote fitting

Device

Processors will be programmed using remote fitting application.

In-Office Fitting

Device

Processors will be programmed using standard Target CI application.

Primary outcomes

Speech Performance in Quiet After Chronic Use (EO Only)

Time frame: 2-3 weeks after fitting

The primary efficacy endpoint is the chronic AzBio sentence recognition scores in quiet captured two-to-three weeks post investigational remote fitting (visit 3) as compared to the chronic AzBio sentence recognition scores in quiet captured two-to-three weeks post control in-office fitting (visit 2). Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome.
Speech Performance in Quiet - Chronic Use (Includes Overall - Both Groups)

Time frame: Test performed 2-3 weeks after fitting

The primary efficacy endpoint is the chronic AzBio sentence recognition scores in quiet captured two-to-three weeks post investigational remote fitting (visit 3) as compared to the chronic AzBio sentence recognition scores in quiet captured two-to-three weeks post control in-office fitting (visit 2). Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome.

Sponsors and collaborators

Lead sponsor

Advanced Bionics

Industry

Registry information

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Sep 5, 2021
Registry last updated: Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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