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

NCT ID: NCT05286385

Last Updated: 2025-02-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-30

Study Completion Date

2022-06-29

Brief Summary

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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

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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.

Conditions

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Hearing Impairment, Sensorineural

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Test Order 1

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

Group Type EXPERIMENTAL

CP1150 Sound Processor

Intervention Type DEVICE

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

CP1150 NF

Intervention Type DEVICE

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

CP1150 + FF

Intervention Type DEVICE

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

CP1110

Intervention Type DEVICE

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

Test Order 2

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

Group Type EXPERIMENTAL

CP1150 Sound Processor

Intervention Type DEVICE

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

CP1150 NF

Intervention Type DEVICE

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

CP1150 + FF

Intervention Type DEVICE

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

CP1110

Intervention Type DEVICE

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

Test Order 3

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

Group Type EXPERIMENTAL

CP1150 Sound Processor

Intervention Type DEVICE

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

CP1150 NF

Intervention Type DEVICE

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

CP1150 + FF

Intervention Type DEVICE

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

CP1110

Intervention Type DEVICE

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

Test Order 4

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

Group Type EXPERIMENTAL

CP1150 Sound Processor

Intervention Type DEVICE

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

CP1150 NF

Intervention Type DEVICE

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

CP1150 + FF

Intervention Type DEVICE

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

CP1110

Intervention Type DEVICE

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

Interventions

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CP1150 Sound Processor

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

Intervention Type DEVICE

CP1150 NF

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

Intervention Type DEVICE

CP1150 + FF

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

Intervention Type DEVICE

CP1110

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

Intervention Type DEVICE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cochlear

INDUSTRY

Sponsor Role lead

Avania

INDUSTRY

Sponsor Role collaborator

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cochlear Sydney

Macquarie Park, New South Wales, Australia

Site Status

Countries

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Australia

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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CLTD5818

Identifier Type: -

Identifier Source: org_study_id

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