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

Not Applicable

Completed

• Conditions: Hearing Impairment, Sensorineural
• Interventions: Device: CP1150 Sound Processor; Device: CP1150 NF; Device: CP1150 + FF; Device: CP1110

• Registration Number: NCT05286385
• Lead Sponsor: Cochlear

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.

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 Timeline

• Study First Submitted: 2022-02-22
• Study First Submitted QC: 2022-03-09
• Study First Posted: 2022-03-18
• Study Start: 2022-05-30
• Primary Completion: 2022-06-29
• Study Completion: 2022-06-29
• Results First Submitted: 2023-01-31
• Status Verified: 2024-02
• Results First Submitted QC: 2024-02-29
• Results First Posted: 2024-08-05
• Last Update Submitted: 2025-01-24
• Last Update Posted: 2025-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Test Order 2	CP1110	CP1150 NF, then CP1150 + FF, then CP1150, then CP1110
Test Order 3	CP1110	CP1150 + FF, then CP1110, then CP1150 NF, then CP1150
Test Order 3	CP1150 NF	CP1150 + FF, then CP1110, then CP1150 NF, then CP1150
Test Order 2	CP1150 NF	CP1150 NF, then CP1150 + FF, then CP1150, then CP1110
Test Order 2	CP1150 + FF	CP1150 NF, then CP1150 + FF, then CP1150, then CP1110
Test Order 1	CP1150 NF	CP1150, then CP1150 NF, then CP1110, then CP1150 + FF
Test Order 1	CP1150 + FF	CP1150, then CP1150 NF, then CP1110, then CP1150 + FF
Test Order 4	CP1150 Sound Processor	CP1110, thenCP1150, then CP1150 + FF, then CP1150 NF
Test Order 1	CP1150 Sound Processor	CP1150, then CP1150 NF, then CP1110, then CP1150 + FF
Test Order 3	CP1150 + FF	CP1150 + FF, then CP1110, then CP1150 NF, then CP1150
Test Order 4	CP1150 NF	CP1110, thenCP1150, then CP1150 + FF, then CP1150 NF
Test Order 2	CP1150 Sound Processor	CP1150 NF, then CP1150 + FF, then CP1150, then CP1110
Test Order 1	CP1110	CP1150, then CP1150 NF, then CP1110, then CP1150 + FF
Test Order 3	CP1150 Sound Processor	CP1150 + FF, then CP1110, then CP1150 NF, then CP1150
Test Order 4	CP1110	CP1110, thenCP1150, then CP1150 + FF, then CP1150 NF
Test Order 4	CP1150 + FF	CP1110, thenCP1150, then CP1150 + FF, then CP1150 NF

Primary Outcome Measures

Name	Time	Method
Speech Perception in Quiet Using an CP1150 Sound Processor	One day (in booth testing)	Paired difference in percentage CNC Words correct in quiet with the CP1150 Sound Processor and CP1150 Sound Processor with modified firmware.

Secondary Outcome Measures

Name	Time	Method
Speech Perception in Quiet With CP1150 and CP1110 Sound Processors	One day (in booth testing)	Paired difference in percentage CNC Words correct in quiet with the CP1150 Sound Processor and CP1110 Sound Processor
Speech Perception in Quiet Using CP1150 Sound Processor Using Forward Focus Combined With Standard Microphone Directionality.	One day (in booth testing)	Paired difference in percentage CNC Words correct in quiet with the CP1150 Sound Processor and CP1150 Sound Processor with forward focus

Trial Locations

Locations (1)

Cochlear Sydney; 🇦🇺 Macquarie Park, New South Wales, Australia