Benefits of the HiResolution Bionic Ear System in Adults With Asymmetric Hearing Loss

July 28, 2023 updated by: Advanced Bionics
The purpose of this feasibility study is to evaluate the benefit of unilateral implantation in adults who have severe to profound sensorineural hearing loss in one ear, and up to moderate sensorineural hearing loss in the other ear (asymmetric hearing loss).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Sarasota, Florida, United States, 34239
        • The Silverstein Institute
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

General Requirements:

  • Ability to provide Informed Consent
  • 18 years of age or older
  • English language proficiency
  • Willingness to participate in all scheduled procedures outlined in the study investigational plan
  • Willingness to use an approved cochlear implant signal processing strategy in an everyday listening program during study

Ear to be Implanted:

  • Severe-to-profound sensorineural hearing loss (> 70 dB HL) as defined by the pure tone average for 500, 1000, 2000 and 4000 Hz
  • CNC word recognition score ≤30% (tested in subject's everyday listening condition for that ear)
  • Duration of severe-to-profound sensorineural hearing loss (≥ 70 dB HL) >3 months and ≤10 years in the ear to be implanted only

Contralateral (non-implanted) ear:

  • Up to a moderate sensorineural hearing loss (<70 dB HL) as defined by the pure tone average for 500, 1000, 2000 and 4000 Hz
  • CNC word recognition score >30% (tested in subject's everyday listening condition for that ear)

Exclusion Criteria:

  • Previous experience with a cochlear implant
  • Cochlear malformation or obstruction (i.e. ossification) that would preclude full insertion of electrode array in the ear to be implanted
  • Medical or psychological conditions that contraindicate surgery or impact the ability to manage an implanted device or the study related procedures as determined by the investigator
  • Diagnosis of auditory neuropathy/dys-synchrony in either the ear to be implanted or the contralateral ear
  • Active middle-ear disease/infection in the ear to be implanted
  • Unrealistic expectations regarding potential benefits, risks and limitations inherent to implant surgical procedures as determined by the investigator
  • Unwillingness or inability of subject to comply with all investigational requirements as determined by the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HiResolution Bionic Cochlear Implant
HiRes 90K™ Advantage implant with HiFocus™ 1J electrode, HiRes 90K™ Advantage implant with the HiFocus Helix™ electrode, HiRes 90K™ Advantage implant with the HiFocus™ Mid-Scala electrode or the HiRes™ Ultra Implant with the HiFocus™ Mid-Scala electrode will be implanted in adults who have severe to profound sensorineural hearing loss in one ear, and up to moderate sensorineural hearing loss in the other ear (asymmetric hearing loss).
Device: HiResolution Bionic Cochlear Implant
HiRes 90K™ Advantage implant with HiFocus™ 1J electrode, HiRes 90K™ Advantage implant with the HiFocus Helix™ electrode, HiRes 90K™ Advantage implant with the HiFocus™ Mid-Scala electrode or the HiRes™ Ultra Implant with the HiFocus™ Mid-Scala electrode will be implanted in adults with eligible hearing profile.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Consonant Nucleus-Consonant (CNC) Word Recognition Test (Implanted Ear Only)
Time Frame: Baseline and Twelve months
The post-implant CNC word scores were compared to preimplant word scores. The CNC monosyllabic word test is a validated test of open-set word recognition ability. The test was administered in quiet at 60 target 0° azimuth) and scored as total number of words correct which is expressed for results/reporting as percentage correct. The CNC word test was the primary speech perception metric used for study inclusion determination and postoperative outcome comparison at defined intervals for this feasibility study. A higher percentage of recognized words represents better hearing of spoken words. The intent is to understand the benefit of the implant treatment option and restoration of auditory input results in improved speech understanding.
Baseline and Twelve months
Change in Unaided Hearing Thresholds (Contralateral, Non-Implanted Ear, Only)
Time Frame: Baseline and Twelve months

Unaided audiometric thresholds compared to preimplant. Standard audiometric procedures were used for the testing of inter-octave frequencies as necessary.

• Unaided air conduction thresholds using insert earphones at octave frequencies were measured for the contralateral, non-implanted ear at 250, 500, 1000, 2000, 4000 and 8000 Hz. Clinical masking was completed as appropriate.
Baseline and Twelve months
Change in Speech Perception (Bilateral Listening Condition) - Speech Front, Noise Front
Time Frame: Baseline and Twelve months
AzBio speech scores in speech front, noise front twelve months post implantation compared to preimplant bilateral sentence scores. The AzBio speech testing was the primary speech perception metric used for baseline and postoperative outcome comparison at defined intervals for this feasibility study. A higher percentage of recognized words represents better hearing of spoken words.
Baseline and Twelve months
Change in Lateralization Ability Testing (Bilateral Listening Condition)
Time Frame: Baseline and Twelve months
Lateralization is ability to recognize the location of sound origin compared to preimplantation. The subject was asked to identify if the sentence was heard from the right or left loudspeaker. Scoring was based on the number of sentence locations correctly identified and expressed as a percent average. A higher percent average indicates a better ability to identify sound location.
Baseline and Twelve months
Change in Speech Perception (Bilateral Listening Condition) - Speech Front/Noise to Implanted Ear
Time Frame: Baseline to Twelve Months
AzBio word scores in speech front, noise to implanted ear twelve months post implantation compared to preimplant bilateral sentence scores. The AzBio speech testing was a speech perception metric used for baseline and postoperative outcome comparison at defined intervals for this feasibility study. A higher percentage of recognized words represents better hearing of spoken words.
Baseline to Twelve Months
Bilateral Listening Condition (Both Ears - Everyday Listening Condition for Each Ear) - Speech Front /Noise to Non-Implanted Ear.
Time Frame: Baseline to Twelve Months
AzBio speech scores in speech front, noise to the contralateral ear at 12 months post implantation compared to preimplant bilateral sentence scores. The baseline speech perception testing was a speech perception metric used for baseline and postoperative outcome comparison at defined intervals for this feasibility study. A higher percentage of recognized words represents better hearing of spoken words.
Baseline to Twelve Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Advanced Bionics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2016

Primary Completion (Actual)

March 25, 2020

Study Completion (Actual)

March 25, 2020

Study Registration Dates

First Submitted

June 7, 2016

First Submitted That Met QC Criteria

June 21, 2016

First Posted (Estimated)

June 23, 2016

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

July 28, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR0314

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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