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

Cochlear1 site in 1 country10 target enrollmentMay 30, 2022

ConditionsHearing Impairment, Sensorineural

Overview

Phase: N/A
Intervention: Not specified
Conditions: Hearing Impairment, Sensorineural
Sponsor: Cochlear
Enrollment: 10
Locations: 1
Primary Endpoint: Speech Perception in Quiet Using an CP1150 Sound Processor
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 30, 2022

End Date

June 29, 2022

Last Updated

last year

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Cochlear

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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).

Outcomes

Primary Outcomes

Speech Perception in Quiet Using an CP1150 Sound Processor

Time Frame: 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 Outcomes

Speech Perception in Quiet With CP1150 and CP1110 Sound Processors(One day (in booth testing))
Speech Perception in Quiet Using CP1150 Sound Processor Using Forward Focus Combined With Standard Microphone Directionality.(One day (in booth testing))