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

The clinical study is designed to evaluate the safety and effectiveness of recipient controlled Bass and Treble.

Study Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2024
      • Sydney Cochlear Implant Centre
    • Sydney, New South Wales, Australia, 2109
      • Cochlear Limited

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 100 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Bass and Treble controls; 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.	Device: Bass and Treble; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 weeks

Other Outcome Measures

Outcome Measure	Time Frame
Subjective daily diary data on the success of the daily Bass and Treble changes made during take-home use	8 weeks
Questionnaire data on the overall subjective ratings of the Bass and Treble controls (importance, confidence, ease and satisfaction)	8 weeks
Incidence of adverse events as well as the severity, relationship to treatment, outcome and actions taken will be listed for each subject and summarised.	8 weeks

Collaborators and Investigators

• Sponsor: Cochlear
• Investigators: Study Director: Chris D Warren, Audiology, Employee

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (ACTUAL): September 1, 2016
• Study Completion (ACTUAL): September 1, 2016

Study Registration Dates

• First Submitted: August 19, 2016
• First Submitted That Met QC Criteria: September 16, 2016
• First Posted (ESTIMATE): September 21, 2016

Study Record Updates

• Last Update Posted (ACTUAL): January 17, 2018
• Last Update Submitted That Met QC Criteria: January 16, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: CLTD5640

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD 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.