Clinical Evaluation of Bass and Treble Controls for CI Subjects

NCT02908737 | Completed

• 1 other identifier: CLTD5640
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

  8 weeks

Other Outcomes (3)

• 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

Study Arms (1)

Bass and Treble controls

EXPERIMENTAL

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

Interventions

Bass and Treble DEVICE

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

Bass and Treble controls

Eligibility Criteria

• Age: 6 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cochlear: lead

Study Sites (2)

Sydney Cochlear Implant Centre

Sydney, New South Wales, 2024, Australia

Location

Cochlear Limited

Sydney, New South Wales, 2109, Australia

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chris D Warren, Audiology

  Employee

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2016
• First Posted: September 21, 2016
• Study Start: July 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: January 17, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)