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

Cochlear

Status: Completed

Conditions: Hearing Impairment, Sensorineural

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05286385

CLTD5818

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10 participants in 4 patient groups

Test Order 1

Experimental group

Description:

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

Treatment:

Device: CP1150 + FF

Device: CP1150 NF

Device: CP1150 Sound Processor

Device: CP1110

Test Order 2

Experimental group

Description:

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

Treatment:

Device: CP1150 + FF

Device: CP1150 NF

Device: CP1150 Sound Processor

Device: CP1110

Test Order 3

Experimental group

Description:

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

Treatment:

Device: CP1150 + FF

Device: CP1150 NF

Device: CP1150 Sound Processor

Device: CP1110

Test Order 4

Experimental group

Description:

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

Treatment:

Device: CP1150 + FF

Device: CP1150 NF

Device: CP1150 Sound Processor

Device: CP1110