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

Cochlear

Status: Completed

Conditions: Hearing Loss

Treatments: Device: Bass and Treble

Study type: Interventional

Funder types: Industry

Identifiers

NCT02908737

CLTD5640

Details and patient eligibility

About

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

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 6 to 100 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

Bass and Treble controls

Experimental group

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.

Treatment:

Device: Bass and Treble