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

Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05034731
• Other study ID #: CR0121
• Status: Completed
• Start date: August 18, 2021
• Est. completion date: May 23, 2022

Study information

• Verified date: August 2023
• Source: Advanced Bionics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective within-subjects repeated-measures study that will enroll 17 users 13 years or older implanted with a HiResolution Bionic Ear System.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: May 23, 2022
• Est. primary completion date: May 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ear Diseases
• Hearing Disorders
• Hearing Loss
• Otolaryngological Disease
• Otorhinolaryngologic Diseases

Intervention

Device:
• Remote Fitting
Processors will be programmed using remote fitting application.
• In-Office Fitting
Processors will be programmed using standard Target CI application.

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Advanced Bionics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Speech Performance in Quiet After Chronic Use (EO Only)	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.	2-3 weeks after fitting
Primary	Speech Performance in Quiet - Chronic Use (Includes Overall - Both Groups)	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.	Test performed 2-3 weeks after fitting