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CP1150 Sound Processor Speech Perception Compared With the Next Generation of Signal Processing Technology

Sponsor
Cochlear (Industry)
Overall Status
Completed
CT.gov ID
NCT05286385
Collaborator
Avania (Industry)
10
Enrollment
1
Location
4
Arms
30
Actual Duration (Days)
10.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This clinical study aims to investigate speech performance in quiet with an OTE Sound Processor with modified firmware compared with the commercially available CP1150. The study also investigates CP1110 and CP1150 with Forward Focus.

Condition or Disease Intervention/Treatment Phase
  • Device: CP1150 Sound Processor
  • Device: CP1150 (modified firmware)
  • Device: CP1150 + FF
  • Device: CP1110
 N/A

Detailed Description

This study will build on the evidence previously collected on OTE and BTE Sound Processors and will support the design goals for access to the same sound processing algorithms across future OTE and BTE variants, including evidence required on the automation of FF and future implant compatibility.

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
A Pre-Marketing, Prospective, Single-Site, Open-Label, Within-Subject, Pilot, Interventional Study of Adult Cochlear Implant Speech Perception With the CP1150 Sound Processor Compared With the Next Generation of Signal Processing Technology
Actual Study Start Date :
May 30, 2022
Actual Primary Completion Date :
Jun 29, 2022
Actual Study Completion Date :
Jun 29, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: CP1150

CP1150 will be used as the comparator device for speech perception testing in quiet.

Device: CP1150 Sound Processor
Speech perception tests whilst the subject is fitted with the CP1150 Sound Processor
Experimental: CP1150 (modified firmware)

CP1150 Sound Processor with modified firmware.

Device: CP1150 (modified firmware)
Speech perception tests whilst the subject is fitted with the CP1150 modified firmware.
Experimental: CP1150 + FF

CP1150 Sound Processor with ForwardFocus.

Device: CP1150 + FF
Speech perception tests whilst the subject is fitted with the CP1150 Sound Processor with ForwardFocus.
Experimental: CP1110

CP1110 is a BTE Sound Processor.

Device: CP1110
Speech perception tests whilst the subject is fitted with the CP1110 Sound Processor.

Outcome Measures

Primary Outcome Measures

  1. Speech perception in quiet using an OTE Sound Processor [One day]

    Paired difference in percentage CNC Words correct in quiet with the CP1150 Sound Processor and CP1150 Sound Processor with modified firmware.

Secondary Outcome Measures

  1. Speech perception in quiet using an OTE Sound Processor using FF combined with standard microphone directionality [One day]

    Paired difference in percentage CNC Words correct in quiet with the CP1150 Sound Processor and CP1150 Sound Processor with FF

  2. Speech perception in quiet with CP1150 and CP1110 Sound Processors [One day]

    Paired difference in percentage CNC Words correct in quiet with the CP1150 Sound Processor and CP1110 Sound Processor

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Aged 18 years or older

  2. Post lingually deafened

  3. Implanted with the CI600 Series, CI500 Series or Freedom Series

  4. At least 6 months experience with a cochlear implant.

  5. At least 3 months experience with a CP910/920, CP950, CP1150, or CP1000 Sound Processor

  6. MAP Total Stimulation Rate of 7.2kHz or greater

  7. Able to score 30% or more with CI alone on a monosyllabic words in quiet test

  8. Willingness to participate in and to comply with all requirements of the protocol

  9. Fluent speaker in English as determined by the investigator

  10. Willing and able to provide written informed consent

Exclusion Criteria:

  1. Additional disabilities that would prevent participation in evaluations.

  2. Implant location that would result in undesirable hearing performance or discomfort with an off-the-ear sound processor, as determined by the investigator.

  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 unless (if less than 30 days) the prior investigation was Cochlear sponsored and determined by the investigator to not impact clinical findings of this investigation.

  7. Implanted with other active implantable medical devices (e.g. pacemaker, defibrillator).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cochlear Sydney Macquarie Park New South Wales Australia 2109

Sponsors and Collaborators

  • Cochlear
  • Avania

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cochlear
ClinicalTrials.gov Identifier:
NCT05286385
Other Study ID Numbers:
  • CLTD5818
First Posted:
Mar 18, 2022
Last Update Posted:
Jul 7, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Loss, Sensorineural

Study Results

No Results Posted as of Jul 7, 2022