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Completed

NCT Number: NCT02908737

Clinical Evaluation of Bass and Treble Controls for CI Subjects

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

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Key information

Conditions

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

Age range

6 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cochlear Limited, Sydney, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

Primary outcomes

  1. Non-inferior speech perception with preferred Bass and Treble settings compared to the baseline Bass and Treble settings

    Time frame: 8 weeks

    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.

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

    Time frame: 8 weeks

    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.

Other outcomes

  1. Subjective daily diary data on the success of the daily Bass and Treble changes made during take-home use

    Time frame: 8 weeks

  2. Questionnaire data on the overall subjective ratings of the Bass and Treble controls (importance, confidence, ease and satisfaction)

    Time frame: 8 weeks

  3. Incidence of adverse events as well as the severity, relationship to treatment, outcome and actions taken will be listed for each subject and summarised.

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Cochlear

Industry

Registry information

Acronym: CLASS

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Sep 21, 2016
Registry last updated
Jan 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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