CP1110 Sound Processor Feasibility

NCT ID: NCT04898673

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-25
• Study Completion Date: 2021-12-16

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 Scene Classifier..

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 Processor when compared to the CP1000 Sound Processor.

To assess the primary and secondary speech perception objectives, the study incorporates a within-subject repeated-measures design in which each subject will undergo in-booth speech perception testing with all combinations of hardware and signal processing settings in a sound booth. The average difference scores will indicate the performance difference for each of the paired comparisons.

Conditions

Adult Cochlear Implant Recipients

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CP1000 Sound Processor followed by the CP1110 Sound Processor

All study subjects were provided with a unique identifier. The ones that ended in an odd number were administered the CP1000 Sound Processor followed by the CP1110 Sound Processor.

Group Type: EXPERIMENTAL

CP1110

Intervention Type: DEVICE

Sound Processor

CP1000

Intervention Type: DEVICE

Sound Processor

CP1110 Sound Processor followed by the CP1000 Sound Processor

All study subjects were provided with a unique identifier. The ones that ended in an even number were administered the CP1110 Sound Processor followed by the CP1000 Sound Processor.

Group Type: EXPERIMENTAL

CP1110

Intervention Type: DEVICE

Sound Processor

CP1000

Intervention Type: DEVICE

Sound Processor

Interventions

CP1110

Sound Processor

Intervention Type: DEVICE

CP1000

Sound Processor

Intervention Type: DEVICE

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) or Freedom Series (CI24RE(CA), CI24RE(ST), CI422)

4. At least 6 months experience with a cochlear implant.

5. At least 3 months experience with a Nucleus 6 (CP910/920), Kanso (CP950), Kanso 2 (CP1150) or Nucleus 7 (CP1000) Sound Processor

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.

6. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Avania

INDUSTRY

Sponsor Role: collaborator

Cochlear

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cochlear Sydney

Sydney, New South Wales, Australia

Countries

Australia

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CLTD5804

Identifier Type: -

Identifier Source: org_study_id