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

NCT05080283 | Completed Results

• 1 other identifier: CLTD5810
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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'.

Conditions

Adult Cochlear Implant Recipients

Outcome Measures

Primary Outcomes (1)

• Speech Reception Thresholds (SRT) Assessed in Spatially Separated Speech and Noise (S0Nrearhalf)

  Paired difference in dB SRT (AuSTIN) between the CP1110 Sound Processor with automated ForwardFocus ON (SCAN 2 FF) and ForwardFocus OFF (SCAN 2) in 65 dB SPL S0Nrearhalf 4TB.

  6 months

Secondary Outcomes (3)

• Speech Reception Thresholds (SRT) Assessed in Spatially Separated Speech and Noise (S0N3)

  6 months

• Adult Cochlear Implant Recipient Speech Perception in Quiet With the CP1110 Sound Processor and the Nucleus 7 Sound Processor

  6 months

• Adult Cochlear Implant Subjective Hearing Performance and Sound Quality With the CP1110 Sound Processor and Nucleus 7 Sound Processor

  Baseline (Nucleus 7) and Visit 2 (6 months, CP1110)

Study Arms (1)

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

OTHER

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.

Device: CP1110 Sound Processor System with automated ForwardFocus On (SCAN 2 FF); Device: Nucleus 7 Sound Processor (model: CP1000) system; Device: CP1110 Sound Processor System with ForwardFocus Off (SCAN 2)

Interventions

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

Sound Processor

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

Nucleus 7 Sound Processor (model: CP1000) system DEVICE

Sound Processor

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

CP1110 Sound Processor System with ForwardFocus Off (SCAN 2) DEVICE

Sound Processor

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or older.
• Post lingually deafened.
• Implanted with the CI600 Series (CI612, CI632, CI622, CI624), CI500 Series (CI512, CI532, CI522) or Freedom Series (CI24RE(CA), CI24RE(ST), CI422).
• At least 6 months experience with a cochlear implant.
• At least 3 months experience with a Nucleus 7 (CP1000) Sound Processor
• Able to score 30% or more at +15 SNR with CI alone on a sentence in babble test
• Willingness to participate in and to comply with all requirements of the protocol.
• Fluent speaker in English as determined by the investigator
• Willing and able to provide written informed consent

You may not qualify if:

• Additional disabilities that would prevent participation in evaluations.
• Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedures.
• Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
• Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
• Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.
• 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.

Sponsors & Collaborators

• Cochlear: lead
• Avania: collaborator

Study Sites (1)

Cochlear Sydney

Sydney, New South Wales, 2109, Australia

Location

Related Publications (1)

• 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.

  PMID: 41046328 DERIVED

MeSH Terms

Interventions

Drug Delivery Systems

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Results Point of Contact

• Title: PRS Specialist, Clinical Affairs
• Organization: Cochlear Ltd.

cltd-prs-admin@cochlear.com

+61 2 9428 6555

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, pre-market, single-site, non-randomized.

Study Record Dates

• First Submitted: September 19, 2021
• First Posted: October 15, 2021
• Study Start: November 2, 2021
• Primary Completion: September 13, 2022
• Study Completion: September 13, 2022
• Last Updated: March 25, 2025
• Results First Posted: March 25, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)