Clinical Evaluation of Bass and Treble Controls for CI Subjects

Hearing Loss Clinical Trial

— CLASS  

Official title:

Clinical Evaluation of Bass and Treble Controls for CI Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02908737
• Other study ID #: CLTD5640
• Status: Completed
• Phase: N/A
• First received: August 19, 2016
• Last updated: January 16, 2018
• Start date: July 2016
• Est. completion date: September 2016

Study information

• Verified date: January 2018
• Source: Cochlear
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss

Intervention

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

Locations

Country	Name	City	State
Australia	Cochlear Limited	Sydney	New South Wales
Australia	Sydney Cochlear Implant Centre	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Cochlear

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subjective daily diary data on the success of the daily Bass and Treble changes made during take-home use		8 weeks
Other	Questionnaire data on the overall subjective ratings of the Bass and Treble controls (importance, confidence, ease and satisfaction)		8 weeks
Other	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
Primary	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	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