Status:
RECRUITING
New Algorithms to Signal Processing for Speech Enhancement in Adult Cochlear Implant Recipients.
Lead Sponsor:
Cochlear
Conditions:
Hearing Loss
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this clinical investigation is to develop pre-processing strategies to enhance speech and reduce noise for CI listeners. The Master Umbrella Clinical Investigation will be comprised of ...
Detailed Description
This is a feasibility, prospective, multi-center, single-subject, repeated-measures clinical investigation in experienced adult cochlear implant users. The Master Umbrella design will enable the execu...
Eligibility Criteria
Inclusion
- User of an approved Nucleus cochlear implant.
- User of the ACE (Advanced Combination Encoder) sound processing strategy.
- Aged 18 years or older (no upper age limit).
- Able to score 20% or more at +10 dB SNR or have an adaptive Speech Recognition Threshold (SRT) of 12 dB or less CI alone on a sentence in babble test.\*
- Fluent speaker in the language used to assess speech perception performance, as determined by the investigator.
- Willing and able to provide written informed consent.
- ≥3 months post cochlear implant activation
Exclusion
- 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 the investigator's immediate families; immediate family is defined as a spouse, parent, child, or sibling.
- Cochlear employees or employees of Contract Research Organizations 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).
Key Trial Info
Start Date :
February 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06100393
Start Date
February 22 2024
End Date
October 31 2026
Last Update
December 5 2025
Active Locations (2)
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1
Cochlear Melbourne
Melbourne, Victoria, Australia, 3002
2
HEARnet Clinical Studies
Melbourne, Victoria, Australia, 3053