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

NCT05286385 | Completed Results

• 1 other identifier: CLTD5818
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Impairment, Sensorineural

Outcome Measures

Primary Outcomes (1)

• Speech Perception in Quiet Using an CP1150 Sound Processor

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

  One day (in booth testing)

Secondary Outcomes (2)

• Speech Perception in Quiet Using CP1150 Sound Processor Using Forward Focus Combined With Standard Microphone Directionality.

  One day (in booth testing)

• Speech Perception in Quiet With CP1150 and CP1110 Sound Processors

  One day (in booth testing)

Study Arms (4)

Test Order 1

EXPERIMENTAL

CP1150, then CP1150 NF, then CP1110, then CP1150 + FF

Device: CP1150 Sound Processor; Device: CP1150 NF; Device: CP1150 + FF; Device: CP1110

Test Order 2

EXPERIMENTAL

CP1150 NF, then CP1150 + FF, then CP1150, then CP1110

Device: CP1150 Sound Processor; Device: CP1150 NF; Device: CP1150 + FF; Device: CP1110

Test Order 3

EXPERIMENTAL

CP1150 + FF, then CP1110, then CP1150 NF, then CP1150

Device: CP1150 Sound Processor; Device: CP1150 NF; Device: CP1150 + FF; Device: CP1110

Test Order 4

EXPERIMENTAL

CP1110, thenCP1150, then CP1150 + FF, then CP1150 NF

Device: CP1150 Sound Processor; Device: CP1150 NF; Device: CP1150 + FF; Device: CP1110

Interventions

CP1150 Sound Processor DEVICE

Speech perception tests whilst the subject is fitted with the CP1150 Sound Processor

Test Order 1; Test Order 2; Test Order 3; Test Order 4

CP1150 NF DEVICE

Speech perception tests whilst the subject is fitted with the CP1150 modified firmware (the addition of notch filters at 978Hz, 1956Hz, 2934Hz, 3912Hz).

Test Order 1; Test Order 2; Test Order 3; Test Order 4

CP1150 + FF DEVICE

Speech perception tests whilst the subject is fitted with the CP1150 Sound Processor with ForwardFocus.

Test Order 1; Test Order 2; Test Order 3; Test Order 4

CP1110 DEVICE

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

Test Order 1; Test Order 2; Test Order 3; Test Order 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• 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, CI500 Series or Freedom Series
• At least 6 months experience with a cochlear implant.
• At least 3 months experience with a CP910/920, CP950, CP1150, or CP1000 Sound Processor
• MAP Total Stimulation Rate of 7.2kHz or greater
• Able to score 30% or more with CI alone on a monosyllabic words in quiet 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.
• Implant location that would result in undesirable hearing performance or discomfort with an off-the-ear sound processor, as determined by the investigator.
• 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 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.
• Implanted with other active implantable medical devices (e.g. pacemaker, defibrillator).

Sponsors & Collaborators

• Cochlear: lead
• Avania: collaborator

Study Sites (1)

Cochlear Sydney

Macquarie Park, New South Wales, 2109, Australia

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

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

cltd-prs-admin@cochlear.com

+61294286555

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: March 18, 2022
• Study Start: May 30, 2022
• Primary Completion: June 29, 2022
• Study Completion: June 29, 2022
• Last Updated: February 7, 2025
• Results First Posted: August 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)