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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02984748
Other study ID # CLTD 5565
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 7, 2014
Est. completion date December 2020

Study information

Verified date July 2021
Source The Hearing Cooperative Research Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 267
Est. completion date December 2020
Est. primary completion date March 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
Cochlear implant


Locations

Country Name City State
Australia The HEARing CRC Melbourne Victoria

Sponsors (4)

Lead Sponsor Collaborator
The Hearing Cooperative Research Centre Attune Hearing, Cochlear, Sydney Cochlear Implant Clinic

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Speech recognition in quiet Speech recognition scores in quiet Testing over 12 months
Primary Speech recognition in noise Speech recognition scores in noise Testing over 12 months
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