Clinical trial NCT05619575: Acceptance and Performance of the CP1170 Sound Processor in Experienced Adult Cochlear Implant Recipients (POLAR)
Official title: A Pre-market, Open-label, Within Subject Study, of Acceptance and Performance of the CP1170 Sound Processor in Experienced Adult Cochlear Implant Recipients Compared with the CP1150 Sound Processor and Their Current Sound Processor.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Impairment
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
Collaborators: name: Avania
First posted: 2022-11-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: Acceptance and performance of the CP1170 sound processor in experienced adult cochlear implant recipients compared with the CP1150 sound processor and their current sound processor.

Detailed description: This investigation is planned to investigate the performance and clinical benefits of features that are new to the CP 1170 Sound Processor. This study will build on the evidence previously collected on OTE (off the ear) sound processors and ForwardFocus, with particular focus on the acceptance and satisfaction of the automation of ForwardFocus in the CP1170 Sound Processor and associated components in general.

Eligibility criteria: Inclusion Criteria:

1. Aged 18 years or older
2. Post lingually deafened
3. Implanted with the CI600 Series (CI612, CI632, CI622, CI624), CI500 Series (CI512, CI532, CI522); Freedom Series (CI24RE(CA), CI24RE(ST), CI422) or N24 Series (CIC3).
4. At least 6 months experience with a cochlear hearing implant
5. At least 3 months experience with any Nucleus sound processor and SCAN program
6. Able to score 30% or more at +15 SNR with CI alone on a sentence in babble test
7. Willingness to participate in and to comply with all requirements of the protocol
8. Fluent speaker in English as determined by the investigator
9. 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 the possible benefits, risks and limitations that are inherent to the procedures
3. Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator
4. Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling
5. Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation, as determined by the Investigator.
6. 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).

Primary outcomes:
measure: Speech perception testing - Speech in Noise using CP1170 sound processor using FF (forwardfocus)
timeFrame: One day (in booth testing)
Secondary outcomes:
measure: Speech perception testing - Speech in Noise using CP1170 sound processor using FF (forwardfocus)
timeFrame: One day (in booth testing)
measure: Speech perception in quiet with CP1170 and CP1150 Sound Processors
timeFrame: One day (in booth testing)
measure: Subjective acceptance and satisfaction between the CP1170 sound processor and the subject's own processor.
timeFrame: 2 weeks
measure: Subjective hearing performance between the CP1170 sound processor and the subject's own processor
timeFrame: One day
Other outcomes:
Locations:
city: Macquarie
country: Australia
facility: Cochlear Macquarie
state: Sydney
Study officials:
References: