Clinical trial NCT02908737: Clinical Evaluation of Bass and Treble Controls for CI Subjects
Official title: Clinical Evaluation of Bass and Treble Controls for CI Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
First posted: 2016-09-21
Enrollment: 34
Sex: ALL
Minimum age (years): 6
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Non-inferior speech perception with preferred Bass and Treble settings compared to the baseline Bass and Treble settings
timeFrame: 8 weeks
Secondary outcomes:
measure: 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
timeFrame: 8 weeks
Other outcomes:
measure: Subjective daily diary data on the success of the daily Bass and Treble changes made during take-home use
timeFrame: 8 weeks
measure: Questionnaire data on the overall subjective ratings of the Bass and Treble controls (importance, confidence, ease and satisfaction)
timeFrame: 8 weeks
measure: Incidence of adverse events as well as the severity, relationship to treatment, outcome and actions taken will be listed for each subject and summarised.
timeFrame: 8 weeks
Locations:
city: Sydney
country: Australia
facility: Sydney Cochlear Implant Centre
state: New South Wales
city: Sydney
country: Australia
facility: Cochlear Limited
state: New South Wales
Study officials:
affiliation: Employee
name: Chris D Warren, Audiology
role: STUDY_DIRECTOR
References: