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Clinical Evaluation of Bass and Treble Controls for CI Subjects (CLASS)

Primary Purpose

Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Bass and Treble
Sponsored by
Cochlear
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss

Eligibility Criteria

6 Years - 100 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Six years of age or older
  2. At least 3 months experience with the CP810, CP910 or CP920 sound processor
  3. At least 3 months experience with the CI24RE or CI500 series implant
  4. Willingness to participate in and to comply with all requirements of the protocol

Exclusion Criteria:

  1. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and prosthetic device
  2. Additional disabilities that would prevent participation in evaluations

Sites / Locations

  • Sydney Cochlear Implant Centre
  • Cochlear Limited

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bass and Treble controls

Arm Description

Bass and Treble controls are clinician enabled and provide the recipient with access to the adjustment of low and high frequency sound balance, known as Bass and Treble respectively.

Outcomes

Primary Outcome Measures

Non-inferior speech perception with preferred Bass and Treble settings compared to the baseline Bass and Treble settings
Co-primary endpoint #1: This endpoint is to test that speech perception scores in noise with preferred Bass and Treble settings are non-inferior to the baseline settings. Subjects will be tested at visit one with their own settings (Baseline), and then again after four weeks use of the Bass and Treble feature. The speech signal will arrive from zero degrees azimuth at a level of 65 dB SPL, the noise will also arrive from zero degrees azimuth, however the noise will adapt according to subject responses. o-primary endpoint #2: This endpoint is to test that speech perception scores in quiet with preferred Bass and Treble settings are non-inferior to the baseline settings. Subjects will be tested at visit one with their own settings (Baseline), and then again after four weeks use of the Bass and Treble feature. The speech signal will arrive from zero degrees azimuth at a level of 50 dB SPL.

Secondary Outcome Measures

Non-inferior sentence recognition in four-talker babble noise with Bass and Treble values set to the minimum (-6 Bass, - 6 Treble) compared to the baseline condition when the speech and noise are from the front
Secondary endpoint #1: This endpoint is to test that speech perception scores in noise with Bass and Treble settings set to minimum (-6, -6) are non-inferior to the baseline settings. Subjects will be tested at visit one. The speech signal will arrive from zero degrees azimuth at a level of 65 dB SPL, the noise will also arrive from zero degrees azimuth, however the noise will adapt according to subject responses.

Full Information

First Posted
August 19, 2016
Last Updated
January 16, 2018
Sponsor
Cochlear
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1. Study Identification

Unique Protocol Identification Number
NCT02908737
Brief Title
Clinical Evaluation of Bass and Treble Controls for CI Subjects
Acronym
CLASS
Official Title
Clinical Evaluation of Bass and Treble Controls for CI Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cochlear

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The clinical study is designed to evaluate the safety and effectiveness of recipient controlled Bass and Treble.
Detailed Description
Bass and Treble controls provide the CI recipient with access to the adjustment of low and high frequency sound balance, known as Bass and Treble respectively. The clinical study is designed to evaluate the safety and effectiveness of recipient controlled Bass and Treble. Subjects will have access to the Bass and Treble controls during a 4 week take-home period, and will complete questionnaires and diaries to provide descriptive data on the Bass and Treble adjustments made during take home use, and the success of these adjustments. Pre and post intervention speech test results will be used to evaluate the effect of access to Bass and Treble controls on speech perception. The post intervention questionnaire will provide information on the overall ratings of the Bass and Treble controls.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bass and Treble controls
Arm Type
Experimental
Arm Description
Bass and Treble controls are clinician enabled and provide the recipient with access to the adjustment of low and high frequency sound balance, known as Bass and Treble respectively.
Intervention Type
Device
Intervention Name(s)
Bass and Treble
Intervention Description
Bass and Treble controls are clinician enabled and provide the recipient with access to the adjustment of low and high frequency sound balance, known as Bass and Treble respectively
Primary Outcome Measure Information:
Title
Non-inferior speech perception with preferred Bass and Treble settings compared to the baseline Bass and Treble settings
Description
Co-primary endpoint #1: This endpoint is to test that speech perception scores in noise with preferred Bass and Treble settings are non-inferior to the baseline settings. Subjects will be tested at visit one with their own settings (Baseline), and then again after four weeks use of the Bass and Treble feature. The speech signal will arrive from zero degrees azimuth at a level of 65 dB SPL, the noise will also arrive from zero degrees azimuth, however the noise will adapt according to subject responses. o-primary endpoint #2: This endpoint is to test that speech perception scores in quiet with preferred Bass and Treble settings are non-inferior to the baseline settings. Subjects will be tested at visit one with their own settings (Baseline), and then again after four weeks use of the Bass and Treble feature. The speech signal will arrive from zero degrees azimuth at a level of 50 dB SPL.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Non-inferior sentence recognition in four-talker babble noise with Bass and Treble values set to the minimum (-6 Bass, - 6 Treble) compared to the baseline condition when the speech and noise are from the front
Description
Secondary endpoint #1: This endpoint is to test that speech perception scores in noise with Bass and Treble settings set to minimum (-6, -6) are non-inferior to the baseline settings. Subjects will be tested at visit one. The speech signal will arrive from zero degrees azimuth at a level of 65 dB SPL, the noise will also arrive from zero degrees azimuth, however the noise will adapt according to subject responses.
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Subjective daily diary data on the success of the daily Bass and Treble changes made during take-home use
Time Frame
8 weeks
Title
Questionnaire data on the overall subjective ratings of the Bass and Treble controls (importance, confidence, ease and satisfaction)
Time Frame
8 weeks
Title
Incidence of adverse events as well as the severity, relationship to treatment, outcome and actions taken will be listed for each subject and summarised.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Six years of age or older At least 3 months experience with the CP810, CP910 or CP920 sound processor At least 3 months experience with the CI24RE or CI500 series implant Willingness to participate in and to comply with all requirements of the protocol Exclusion Criteria: Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and prosthetic device Additional disabilities that would prevent participation in evaluations
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris D Warren, Audiology
Organizational Affiliation
Employee
Official's Role
Study Director
Facility Information:
Facility Name
Sydney Cochlear Implant Centre
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2024
Country
Australia
Facility Name
Cochlear Limited
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2109
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Identifiable data will not be made available to the public. Data will be kept in a secure, locked environment and only the researchers working on the study, relevant authorities and authorised representatives will have access to it. Subject health records and any information obtained during the research project are subject to inspection (for the purpose of verifying the procedures and the data) by the Food and Drug Administration (FDA) of the United States of America, other national drug regulatory authorities and such as the Australian Government's Therapeutic Goods Administration (TGA), local Ethics Committees, and other duly authorised representatives of the Sponsor, or as required by law. Study subjects have consented to this.

Learn more about this trial

Clinical Evaluation of Bass and Treble Controls for CI Subjects

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