Outcome Prediction in Cochlear Implant Recipients

Hearing Loss Clinical Trial

Official title:

Prediction of Outcomes in Adult Cochlear Implant Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02984748
• Other study ID #: CLTD 5565
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Deafness
• Hearing Loss

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