Outcome Prediction in Cochlear Implant Recipients

Completed

• Conditions: Hearing Loss
• Interventions: Device: Cochlear implant

• Registration Number: NCT02984748
• Lead Sponsor: The Hearing Cooperative Research Centre

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-07
• Study First Submitted: 2016-12-04
• Study First Submitted QC: 2016-12-06
• Study First Posted: 2016-12-07
• Primary Completion: 2019-03
• Study Completion: 2020-12
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-02
• Last Update Posted: 2021-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 267

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cochlear Implant Recipients	Cochlear implant	-

Primary Outcome Measures

Name	Time	Method
Speech recognition in noise	Testing over 12 months	Speech recognition scores in noise
Speech recognition in quiet	Testing over 12 months	Speech recognition scores in quiet

Trial Locations

Locations (1)

The HEARing CRC; 🇦🇺 Melbourne, Victoria, Australia