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

A Pre-Marketing, Prospective, Single-Site, Open-Label, Within-Subject, Actual-Use, Interventional Study of Acceptance and Performance With Experienced Adult Cochlear Implant Recipients Using the CP1110 Sound Processor Compared With the CP1000 Sound Processor

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'.

Study Overview

• Status: Completed
• Conditions: Adult Cochlear Implant Recipients
• Intervention / Treatment: Device: CP1110 Sound Processor System; Device: Nucleus 7 Sound Processor (model: CP1000) system

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'. 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2109
      • Cochlear Sydney

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CP1110 Sound Processor System with ForwardFocus On (SCAN)	Device: CP1110 Sound Processor System; Sound Processor
Experimental: CP1110 Sound Processor System with ForwardFocus Off (SCAN)	Device: CP1110 Sound Processor System; Sound Processor
Active Comparator: Nucleus 7 Sound Processor (model: CP1000) system	Device: Nucleus 7 Sound Processor (model: CP1000) system; Sound Processor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speech Reception Thresholds (SRT) assessed in spatially separated speech and noise (S0Nrearhalf).	Paired difference in dB SRT (AuSTIN) between the CP1110 Sound Processor with ForwardFocus ON (SCAN) and ForwardFocus OFF (SCAN) (65 dB SPL S0Nrearhalf 4TB).	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speech Reception Thresholds (SRT) assessed in spatially separated speech and noise (S0N3).	Paired difference in dB SRT (AuSTIN) between the CP1110 Sound Processor with ForwardFocus On (SCAN) and ForwardFocus OFF (SCAN) (65 dB SPL S0N3 Babble).	6 months
Adult cochlear implant speech perception in quiet with the CP1110 Sound Processor and the Nucleus 7 Sound Processor.	Paired difference in percentage CNC Words correct in quiet (50 dB) with the CP1110 Sound Processor and 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.	Paired difference in Global Speech, Spatial and Qualities of Hearing Scale SSQ12 scores after experience with the CP1110 Sound Processor and Nucleus 7 Sound Responses on the SSQ12 have a minimum value of 0 and a maximum of 10, wherein a higher score means a better outcome.	6 months
To evaluate acceptance and satisfaction of the CP1110 Sound Processor.	Responses on the 'CP1110 Questionnaire 1' after at least 2 weeks of experience with the CP1110 Sound Processor and 'CP1110 Questionnaire 2' up to 6 months later.	6 months

Collaborators and Investigators

• Sponsor: Cochlear
• Collaborators: Avania

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2021
• Primary Completion (Actual): September 13, 2022
• Study Completion (Actual): September 13, 2022

Study Registration Dates

• First Submitted: September 19, 2021
• First Submitted That Met QC Criteria: October 13, 2021
• First Posted (Actual): October 15, 2021

Study Record Updates

• Last Update Posted (Actual): September 16, 2022
• Last Update Submitted That Met QC Criteria: September 14, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CLTD5810

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No