Evaluation of the CP1000 Sound Processor and Compatible Products : V3
Research type
Research Study
Full title
Evaluation of Subjective Ratings on the CP1000 Sound Processor and Compatible Products
IRAS ID
208203
Contact name
Helen Cullington
Contact email
Sponsor organisation
Cochlear Limited
Clinicaltrials.gov Identifier
ERGO 23012, University of Southampton
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
Cochlear implants have been highly successful in restoring speech understanding to individuals with moderately severe-to-profound hearing loss. These patients always have to wear an external sound processor in order to hear sound. The sound processor is usually worn behind the ear and patients can use either the buttons on the processor to change settings or they can use an accessory called a remote assistant.
The CP1000 Sound Processor and compatible products offer a number of design improvements over previous generation sound processors and controls. The current study aims to collect subjective ratings of the CP1000 Sound Processor and compatible products to compare with ratings of each subjects’ own sound processor and controls.
The primary objective of this study is to assess whether subjective group mean ratings of satisfaction with the CP1000 Sound Processor and compatible products are non-inferior to that of subject’s own devices. The study will implement a repeated measures, within subject design in which each subject will complete the questionnaire with their own sound processor at visit 1 (baseline) and again after use with the CP1000 Sound Processor and compatible products (visit 3 – 3 month). This approach will provide two data points for each subject with which to run statistical analyses.
An improvement scale will be used at visit one to identify listening situations that each subject would like to have improved with the new sound processor. At visit 3 (3 month) the change in hearing function for each of the identified listening situations will be recorded.
Questionnaire data will also be collected on hearing performance, connectivity, streaming, phone use, comfort, retention, ease of use and controls associated with their own sound processor and the CP1000 Sound Processor during take-home use.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
16/EM/0338
Date of REC Opinion
13 Oct 2016
REC opinion
Further Information Favourable Opinion