Non-significant Risk Study of a Cochlear Implant Headpiece

October 24, 2023 updated by: Advanced Bionics
This study aims to evaluate a cochlear implant headpiece.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The headpiece and magnet are expected to provide acceptable comfort and retention for existing cochlear implant users. In this study participants will report on their experience with the investigational headpiece during daily life.

Study Type

Interventional

Enrollment (Actual)

101

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
    • California
      • Valencia, California, United States, 91355
        • Advanced Bionics

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Pre- or post-lingually deafened.
  • Fluent in English, French, or Spanish or capable of communication with a caregiver who is providing consent.
  • Adult or child implanted with a commercially available Advanced Bionics cochlear implant. Children and adult participants are included to ensure device retention is appropriate for all implant populations.
  • Have (or caregivers have) the cognitive and functional capability to comply with all directions during the study
  • Be able to remove their own headpiece
  • Have (or caregivers have) the cognitive and functional capability to complete the questionnaire required for the study
  • Capable (or caregivers are capable) of reading and understanding patient information materials and giving written informed consent

Exclusion Criteria:

  • Have any significant medical condition that, in the opinion of any of the investigators, is likely to interfere with study procedures or likely to confound evaluation of study data.

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: Non-significant risk study of a cochlear implant headpiece
This arm aims to evaluate a cochlear implant headpiece.
Device: cochlear implant headpiece
investigational cochlear implant headpiece

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective Report of Headpiece Comfort and Retention
Time Frame: Assessed every two months from month 2 to month 12, values at study close out (month 12) reported.

Comfort and subjective retention of the headpiece were rated via questionnaire for baseline headpiece and investigational headpiece acute and chronic use. Subjects were provided with ratings questionnaires and asked to chronically evaluate the headpiece and associated magnet for comfort and retention every two months. Results are presented as total count of participants who rated retention and comfort as favorable ("no opinion," "acceptable," or "very acceptable") at study close out.

The baseline/investigational headpiece questionnaires included 2 questions:

  1. Rate the retention of your personal/investigational headpiece (Very acceptable, Acceptable, No Opinion, Unacceptable, Very Unacceptable)
  2. Rate the comfort of your personal headpiece (Very acceptable, Acceptable, No Opinion, Unacceptable, Very Unacceptable)
Assessed every two months from month 2 to month 12, values at study close out (month 12) reported.

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)

February 28, 2019

Primary Completion (Actual)

February 22, 2020

Study Completion (Actual)

February 22, 2020

Study Registration Dates

First Submitted

July 26, 2022

First Submitted That Met QC Criteria

August 3, 2022

First Posted (Actual)

August 4, 2022

Study Record Updates

Last Update Posted (Actual)

November 14, 2023

Last Update Submitted That Met QC Criteria

October 24, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20190256

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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