Clinical trial NCT05286385: CP1150 Sound Processor Speech Perception Compared With the Next Generation of Signal Processing Technology
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Impairment, Sensorineural
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
Collaborators: name: Avania
First posted: 2022-03-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Speech Perception in Quiet Using an CP1150 Sound Processor
timeFrame: One day (in booth testing)
Secondary outcomes:
measure: Speech Perception in Quiet Using CP1150 Sound Processor Using Forward Focus Combined With Standard Microphone Directionality.
timeFrame: One day (in booth testing)
measure: Speech Perception in Quiet With CP1150 and CP1110 Sound Processors
timeFrame: One day (in booth testing)
Other outcomes:
Locations:
city: Macquarie Park
country: Australia
facility: Cochlear Sydney
state: New South Wales
Study officials:
References: