Status:
COMPLETED
CP1110 Sound Processor Feasibility
Lead Sponsor:
Cochlear
Collaborating Sponsors:
Avania
Conditions:
Adult Cochlear Implant Recipients
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The clinical study aims to investigate the speech performance with the CP1110 Sound Processor, compared with the CP1000 Sound Processor, and inclusion of a noise reduction feature in the Automatic Sce...
Detailed Description
The study will build on the evidence previously collected on behind-the-ear sound processors and noise reduction, with particular focus on the speech perception performance of the CP1110 Sound Process...
Eligibility Criteria
Inclusion
- Aged 18 years or older
- Post lingually deafened
- Implanted with the CI600 Series (CI612, CI632, CI622, CI624), CI500 Series (CI512, CI532, CI522) or Freedom Series (CI24RE(CA), CI24RE(ST), CI422)
- At least 6 months experience with a cochlear implant.
- At least 3 months experience with a Nucleus 6 (CP910/920), Kanso (CP950), Kanso 2 (CP1150) or Nucleus 7 (CP1000) Sound Processor
- Able to score 30% or more at +15 SNR with CI alone on a sentence in babble test
- Willingness to participate in and to comply with all requirements of the protocol.
- Fluent speaker in English as determined by the investigator
- Willing and able to provide written informed consent
Exclusion
- Additional disabilities that would prevent participation in evaluations.
- Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedures.
- Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
- 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.
- Currently participating, or participated in another interventional clinical study/trial in the past 30 days, or (if less than 30 days) the prior investigation was Cochlear sponsored and determined by the investigator to not impact clinical findings of this investigation.
Key Trial Info
Start Date :
October 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2021
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04898673
Start Date
October 25 2021
End Date
December 16 2021
Last Update
February 11 2025
Active Locations (1)
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1
Cochlear Sydney
Sydney, New South Wales, Australia, 2109