CP1110 Sound Processor Feasibility

NCT04898673 | Completed Results

• 1 other identifier: CLTD5804
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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..

Conditions

Adult Cochlear Implant Recipients

Outcome Measures

Primary Outcomes (1)

• Speech Reception Thresholds (SRT) Assessed Via Sentence Scores in Spatially Separated Adaptive Noise

  Paired difference in dB SRT between treatment and control, with their applicable noise reduction feature enabled. The speech recognition threshold (SRT) examines at which level the participant can repeat 50% of the speech material correctly. These scores may be negative or positive numeric values. Lower dB SRT scores indicate a better outcome.

  One day

Secondary Outcomes (3)

• Percentage of Correct Words Assessed by CNC (Consonant Nucleus Consonant) Monosyllabic Word Scores in Quiet

  One day

• Percentage of Correct Assessed by CNC (Consonant Nucleus Consonant) Monosyllabic Word Scores in Quiet

  One day

• Percentage of Correct Words Assessed by CNC (Consonant Nucleus Consonant) Monosyllabic Word Scores in Quiet

  One Day

Study Arms (2)

CP1000 Sound Processor followed by the CP1110 Sound Processor

EXPERIMENTAL

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.

Device: CP1110; Device: CP1000

CP1110 Sound Processor followed by the CP1000 Sound Processor

EXPERIMENTAL

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.

Device: CP1110; Device: CP1000

Interventions

CP1110 DEVICE

Sound Processor

CP1000 Sound Processor followed by the CP1110 Sound Processor; CP1110 Sound Processor followed by the CP1000 Sound Processor

CP1000 DEVICE

Sound Processor

CP1000 Sound Processor followed by the CP1110 Sound Processor; CP1110 Sound Processor followed by the CP1000 Sound Processor

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 6 (CP910/920), Kanso (CP950), Kanso 2 (CP1150) or 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

Results Point of Contact

• Title: PRS Specialist, Clinical Affairs
• Organization: Cochlear Limited

cltd-prs-admin@cochlear.com

+61 2 9428 6555

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: prospective, pre-market, Multi-site, non-randomized.

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 24, 2021
• Study Start: October 25, 2021
• Primary Completion: December 16, 2021
• Study Completion: December 16, 2021
• Last Updated: February 11, 2025
• Results First Posted: August 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)