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Clinical Trials/NCT02984748
NCT02984748
Completed
N/A

Prediction of Outcomes in Adult Cochlear Implant Recipients

The Hearing Cooperative Research Centre1 site in 1 country267 target enrollmentOctober 7, 2014
ConditionsHearing Loss

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hearing Loss
Sponsor
The Hearing Cooperative Research Centre
Enrollment
267
Locations
1
Primary Endpoint
Speech recognition in noise
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 7, 2014
End Date
December 2020
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
The Hearing Cooperative Research Centre
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Speech recognition in noise

Time Frame: Testing over 12 months

Speech recognition scores in noise

Speech recognition in quiet

Time Frame: Testing over 12 months

Speech recognition scores in quiet

Study Sites (1)

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