Clinical Evaluation of a Cochlear Implant Sound Processor

Hearing Loss Clinical Trial

Official title:

Evaluation of AutoSense OS on a Cochlear Implant Sound Processor Programmed With Target CI Fitting Software in Adult Users of the HiResolution Bionic Ear System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04237207
• Other study ID #: CR1218
• Status: Completed
• Phase: N/A
• Start date: December 17, 2019
• Est. completion date: October 15, 2020

Study information

• Verified date: April 2022
• 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 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: October 15, 2020
• Est. primary completion date: October 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ear Diseases
• Hearing Disorders
• Hearing Loss
• Otorhinolaryngologic Diseases

Intervention

Device:
• Naída Cochlear Implant Q90 sound processor (Naida CI Q90) & software
Control cochlear implant sound processor
• 301-M062 sound processor & software
New cochlear implant sound processor

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado
United States	Austin Ear, Nose & Throat Clinic	Austin	Texas
United States	Midwest Ear Institute/St. Luke's Health System	Kansas City	Missouri
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Washington University Medical Center	Saint Louis	Missouri
United States	Tampa Bay Hearing and Balance Center	Tampa	Florida

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 Recognition in Quiet	The primary efficacy endpoints are AzBio sentence recognition scores in quiet at Baseline with the new sound processor as compared to AzBio sentence recognition scores in quiet at Baseline with currently approved software on a Q90 processor. Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome.	1 Day
Secondary	Speech Recognition in Noise	Demonstrate that AzBio sentence recognition scores in noise with the new sound processor are no worse than AzBio sentence recognition scores in noise with currently approved software on a Q90 processor. Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome.	1 Day
Secondary	Increased Speech Recognition in Noise	Demonstrate increased AzBio sentence recognition scores in noise with the new sound processor when comparing "Omnidirectional" program to AutoSense. Omnidirectional refers to a setting in which the AutoSense feature is not active. Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome.	1 Day