Acceptance and Performance of the CP1170 Sound Processor in Experienced Adult Cochlear Implant Recipients (POLAR)

Cochlear

Status: Completed

Conditions: Hearing Impairment

Treatments: Device: CP1150 Sound processor; Device: CP1170 sound processor

Study type: Interventional

Funder types: Industry

Identifiers

NCT05619575

CLTD5836

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

CP1170 sound processor

Experimental group

Description:

Take home use of CP1170 Sound processor for 2 weeks followed by in booth testing of the investigational device.

Treatment:

Device: CP1170 sound processor

CP1150 sound processor

Active Comparator group

Description:

In booth testing of CP1150 sound processor.

Treatment:

Device: CP1150 Sound processor

Sponsors of this trial

Lead Sponsor

Cochlear

Collaborating Sponsor

Avania