sability and effectiveness of next generation sound processor used in adult hearing impaired populatio

Not Applicable

Completed

• Conditions: Post Lingual hearing Loss; Ear - Deafness

• Registration Number: ACTRN12619000666123
• Lead Sponsor: Cochlear Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-03
• Study Completion: 2020-08-25
• Last Update Posted: 4 October 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

1. Aged 18 years or older
2. Post lingually deafened
3. Implanted with the CI500 series or Freedom series in at least one ear
4. At least 3 months experience with a cochlear implant
5. Able to complete open set speech perception tests as determined by the investigator
6. Willingness to participate in and to comply with all requirements of the protocol
7. Fluent speaker in the language used to assess speech perception performance as determined by the investigator
8. Willing and able to provide written informed consent

Exclusion Criteria

1. Additional disabilities that would prevent participation in evaluations
2. Unrealistic expectations on the part of the subject, regarding possible benefits, risks and limitation that are inherent to the procedures
3. Implant location that would result in undesirable hearing performance or discomfort, as determined by the investigator
4. Unable or unwilling to comply with the requirements of the clinical investigation, as determined by the investigator
5. Investigator site personnel directly affiliated with this this study and/or their immediate families; immediate family is defined as a spouse, parent, child or sibling
6. Cochlear employees or employees of contract research organisations or contractors engaged by Cochlear for the purposes of this investigation
7. Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device
8. Implanted with other active implantable medical devices (e.g. pacemaker, defibrillator)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Speech Perception (word detection in a noise-controlled environment using AuSTIN adaptive sentences)[Completion of Phase 3<br><br>Phase 1 will take 1 day for each subject to complete – all subjects will subjects will proceed to Phase 2 after completion of all subjects. It is estimated that this will take approximately 4 weeks to complete.<br> <br>Phase 2 will take 4 weeks to complete for each subject – subjects will proceed to Phase 3 after completion of all subjects. It is estimated that this will take approximately 2 months to complete.<br><br>Phase 3 will take 4 weeks to complete for each subject – phase 3 will take about 2 months to complete.]