An Investigation to Evaluate Sound Coding Enhancements in Adult Cochlear Implant Recipients

Not Applicable

Not yet recruiting

• Conditions: Cochlear Implant Recipients; Hearing Loss, Cochlear

• Registration Number: NCT06867380
• Lead Sponsor: Cochlear

Brief Summary

This study will evaluate a range of experimental sound coding strategies that may improve hearing for cochlear implant recipients.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-04
• Study First Submitted QC: 2025-03-06
• Study First Posted: 2025-03-10
• Study Start: 2025-05
• Last Update Submitted: 2025-05-18
• Last Update Posted: 2025-05-20
• Primary Completion: 2030-04
• Study Completion: 2030-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Users of an approved Nucleus cochlear implant.
• Aged 18 years or older (no upper age limit).
• Open set speech understanding sufficient to complete the study protocol as judged by the investigator.
• Fluent speaker in the language used to assess speech perception performance, as determined by the investigator.
• Willing and able to provide written informed consent.

Exclusion Criteria

• Unable or unwilling to comply with the requirements of the clinical investigation as determined by the investigator.
• Additional health factors, known to the investigator, that would prevent or restrict participation in the audiological evaluations.
• Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
• Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation
• Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Paired difference in Speech Reception Threshold (SRT) score (dB) between the investigational sound coding strategy and the default sound coding strategy	0 to 12 weeks	Speech perception in noise will be measured using the Australian Speech Test in Noise (AuSTIN) with speech presented at 65 dB SPL in adaptive 4-talker babble noise, both presented in front of the listener. It is scored as a Speech Reception Threshold (SRT), which reflects the volume of speech signal (in decibels, dB) relative to the background noise required for the subject to achieve 50% correct. For example, a score of 2dB SRT means the subject requires the speech to be 2dB louder than the background noise in order to correctly identify 50% of the target sentence. Range: -30dB to +30dB. Lower scores reflect a better outcome.

Trial Locations

Locations (2)

HEARnet Clinical studies; 🇦🇺 Carlton, Victoria, Australia

Cochlear Melbourne; 🇦🇺 East Melbourne, Victoria, Australia