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

NCT ID: NCT05619575

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-20
• Study Completion Date: 2024-01-10

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 CP1170 Sound Processor. This study will build on the evidence previously collected on off-the-ear (OTE) 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.

Conditions

Hearing Impairment

Study Design

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

Study Groups

CP1170 Sound Processor

Take home use of CP1170 Sound Processor for 2 weeks followed by in-booth testing of this investigational device. The SCAN 2 FF (automated ForwardFocus On) program will be compared to the SCAN 2 (ForwardFocus Off) program in the CP1170 Sound Processor. This investigational device will also be compared to the CP1150 Sound Processor and participants' own sound processor.

Group Type: EXPERIMENTAL

CP1170 Sound Processor

Intervention Type: DEVICE

The CP1170 Sound Processor will be used to determine the hearing performance with the new implementation of ForwardFocus in SCAN 2 (SCAN 2 FF), as assessed by speech perception in noise.

CP1150 Sound Processor

Intervention Type: DEVICE

Active comparator off-the-ear sound processor.

Interventions

CP1170 Sound Processor

The CP1170 Sound Processor will be used to determine the hearing performance with the new implementation of ForwardFocus in SCAN 2 (SCAN 2 FF), as assessed by speech perception in noise.

Intervention Type: DEVICE

CP1150 Sound Processor

Active comparator off-the-ear 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); 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Avania

INDUSTRY

Sponsor Role: collaborator

Cochlear

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cochlear Macquarie

Macquarie, Sydney, Australia

Countries

Australia

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CLTD5836

Identifier Type: -

Identifier Source: org_study_id