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New tests for remote monitoring of cochlear implants

Evaluation of test battery for remote monitoring of cochlear implants

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN13600782
Enrollment
100
Registered
2016-09-22
Start date
2016-05-31
Completion date
Unknown
Last updated
2022-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe to profound deafness Ear, Nose and Throat Hearing loss, unspecified

Interventions

The following procedures that are part of the remote monitoring test battery will be conducted with the patient using a cochlear implant just before they see the clinician or their standard appointmen

Sponsors

Cochlear Ltd (Australia)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Secondary endpoint The acceptance of the concept of remote monitoring for recipients or parent/carers, assessed through the Recipient/Parent Questionnaire at the single study visit Exploratory endpoint 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

Countries

England, Scotland, United Kingdom

Contacts

Public ContactHelen Cullington

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026