ew tests for remote monitoring of cochlear implants

Not Applicable

Completed

• Conditions: Severe to profound deafness; Ear, Nose and Throat; Hearing loss, unspecified

• Registration Number: ISRCTN13600782
• Lead Sponsor: Cochlear Ltd (Australia)

Brief Summary

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34431430/ (added 17/01/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-22
• Study Completion: 2017-02-28
• Last Update Posted: 1 February 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 93

Inclusion Criteria

1. Adults (>18 years) using cochlear implants or children (>4 years) using cochlear implants
2. Implanted with the CI500 series, CI24RE, Nucleus 24 Series or CI422 cochlear implants
3. User of commercially available CP900 series sound processor
4. At least 3 months experience with the cochlear implant
5. Ability to complete closed set speech perception of numbers 0 to 9 in the language used for the Digit Triplet Test (English)
6. Willingness to participate in and to comply with all requirements of the protocol
7. Routine clinical appointment scheduled during the study period

Exclusion Criteria

1. Adults or parents/carers with limited English that would prevent completion of questionnaires
2. Nucleus 22 cochlear implant recipients
3. Additional handicaps that would prevent participation in evaluations
4. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedures

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Whether the test battery provides sufficient information for the clinician to determine if the recipient needs any intervention, assessed through the Clinician Questionnaire at the single study visit

Secondary Outcome Measures

Name	Time	Method
<br> Secondary endpoint<br> The acceptance of the concept of remote monitoring for recipients or parent/carers, assessed through the Recipient/Parent Questionnaire at the single study visit<br><br> Exploratory endpoint<br> Feedback from clinicians regarding any additional clinical metrics that will increase the acceptability of the test battery for remote monitoring captured; collected at the single study visit<br>