Outcome Prediction in Cochlear Implant Recipients

HEARing Cooperative Research Centre (CRC)

Status: Completed

Conditions: Hearing Loss

Treatments: Device: Cochlear implant

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02984748

CLTD 5565

Details and patient eligibility

About

The ability to predict post-operative outcomes after implantation is important for a number of reasons, including being able to advise candidates of appropriate expectations using evidence based guidance. The approved study involves investigation of the ability to predict outcomes in the implanted ear alone and in the best-aided binaural listening conditions, examining a number of measured factors both pre-, peri- and post-operatively. The study incorporates a range of functional outcome measures through questionnaires to ascertain social, functional and demographic factors that may be predictive of outcomes. Questionnaires are also administered to determine the degree of benefit obtained after implantation for each individual, since this forms a key component of providing pre-operative counselling to candidates.

Enrollment: 267 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Clinical suitability for first side implantation, i.e. not undergoing assessment for second side cochlear implant surgery
2. Willing and able to attend the study visits
3. Able to provide informed consent for participation in the study, with an understanding of the requirements, risks and benefits of participation in the investigation
4. Able to read and understand study documents and follow investigator instructions
5. Able to understand and follow study personnel instructions during audiological measurements
6. Native speaker in the language used to assess clinical speech perception performance

Exclusion criteria

1. Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to enrolment in the clinical investigation.

Trial design

267 participants in 1 patient group

Cochlear Implant Recipients

Treatment:

Device: Cochlear implant