N/A
N=10
CP1150 Sound Processor Speech Perception Compared With the Next Generation of Signal Processing Technology
Hearing Impairment, Sensorineural
Bottom Line
View on ClinicalTrials.gov: NCT05286385 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Speech Perception in Quiet Using an CP1150 Sound Processor — 13.82; 11.53 percentage of correct words
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CP1150 Sound Processor (Device); CP1150 NF (Device); CP1150 + FF (Device); CP1110 (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cochlear
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Speech Perception in Quiet Using an CP1150 Sound Processor |
13.82; 11.53 | — |
| SECONDARY Speech Perception in Quiet Using CP1150 Sound Processor Using Forward Focus Combined With Standard Microphone Directionality. |
11.24; 11.53 | — |
| SECONDARY Speech Perception in Quiet With CP1150 and CP1110 Sound Processors |
11.53; 11.97 | — |
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.
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).
Data sourced from ClinicalTrials.gov (NCT05286385). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.