Acceptance and Performance of CP1110 Sound Processor With Experienced Adult Cochlear Implant Recipients.

NCT ID: NCT05080283

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-02
• Study Completion Date: 2022-09-13

Brief Summary

The clinical study aims to investigate acceptance, actual-use usability and speech performance with a new behind-the-ear sound processor (model number: CP1110) system, compared with the commercially available Nucleus 7 Sound Processor (model: CP1000) system, with particular focus on the acceptance of and satisfaction with a noise reduction feature in the Automatic Scene Classifier 'SCAN 2'.

Detailed Description

The clinical study aims to investigate acceptance, actual-use usability and speech performance with a new behind-the-ear sound processor (model number: CP1110) system, compared with the commercially available Nucleus 7 Sound Processor (model: CP1000) system, with particular focus on the acceptance of and satisfaction with a noise reduction feature in the Automatic Scene Classifier 'SCAN 2'. This study will build on the evidence collected in previous Nucleus 7 Sound Processor take home studies and will also aim to confirm the in-booth performance of CP1110 and Nucleus 7 Sound Processors.

Conditions

Adult Cochlear Implant Recipients

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CP1110 with automated ForwardFocus On (SCAN 2 FF), CP1110 with ForwardFocus Off (SCAN 2), and CP1000

All participants assigned to CP1110 Sound Processor System with automated ForwardFocus On (SCAN 2 FF), CP1110 Sound Processor System with ForwardFocus Off (SCAN 2) compared to the previously marketed Nucleus 7 Sound Processor (Model: CP1000) in a random order.

Group Type: OTHER

CP1110 Sound Processor System with automated ForwardFocus On (SCAN 2 FF)

Intervention Type: DEVICE

Sound Processor

Nucleus 7 Sound Processor (model: CP1000) system

Intervention Type: DEVICE

Sound Processor

CP1110 Sound Processor System with ForwardFocus Off (SCAN 2)

Intervention Type: DEVICE

Sound Processor

Interventions

CP1110 Sound Processor System with automated ForwardFocus On (SCAN 2 FF)

Sound Processor

Intervention Type: DEVICE

Nucleus 7 Sound Processor (model: CP1000) system

Sound Processor

Intervention Type: DEVICE

CP1110 Sound Processor System with ForwardFocus Off (SCAN 2)

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 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

References

Nel E, Hong W, Playford J, Mashal ME. A clinical and real-world investigation of cochlear implant recipient speech performance in noise with the automation of ForwardFocus. Int J Audiol. 2025 Oct 4:1-9. doi: 10.1080/14992027.2025.2561889. Online ahead of print.

Reference Type: DERIVED

PMID: 41046328 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CLTD5810

Identifier Type: -

Identifier Source: org_study_id