N/A
N=20
Acceptance and Performance of the CP1170 Sound Processor in Experienced Adult Cochlear Implant Recipients
Hearing Impairment
Bottom Line
View on ClinicalTrials.gov: NCT05619575 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Paired Difference in dB SRT Between the CP1170 SCAN 2 FF (Automated ForwardFocus ON) and CP1170 SCAN 2 (ForwardFocus OFF) in 65 dB SPL (Sound Pressure Level) S0Nrearhalf 4Talker Babble (Speech Perception in Noise) — -6.58; -4.58; -2.00 dB SRT
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CP1170 Sound Processor (Device); CP1150 Sound Processor (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cochlear
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Paired Difference in dB SRT Between the CP1170 SCAN 2 FF (Automated ForwardFocus ON) and CP1170 SCAN 2 (ForwardFocus OFF) in 65 dB SPL (Sound Pressure Level) S0Nrearhalf 4Talker Babble (Speech Perception in Noise) |
-6.58; -4.58; -2.00 | — |
| SECONDARY Paired Difference in dB SRT Between the CP1170 SCAN 2 FF (Automated ForwardFocus ON) and CP1170 SCAN 2 (ForwardFocus OFF) in 65 dB SPL S0N3 Babble (Speech Perception in Noise) |
-4.66; -3.24; -1.43 | — |
| SECONDARY Paired Difference in Percentage CNC (Consonant-nucleus-consonant) Words Correct in Quiet (50 dB) Between the CP1170 Sound Processor and CP1150 Sound Processor (Commercial Version) |
59.06; 56.53; 2.53 | — |
| SECONDARY Subjective Acceptance and Satisfaction Between the CP1170 Sound Processor and the Subject's Own Processor |
16; 18 | — |
| SECONDARY Paired Difference in Global SSQ12 Scores After Experience With the CP1170 Sound Processor and Own Processor |
6.07; 6.06; 0.10 | — |
Summary
Acceptance and performance of the CP1170 sound processor in experienced adult cochlear implant recipients compared with the CP1150 sound processor and their current sound processor.
Eligibility Criteria
Inclusion Criteria
- Aged 18 years or older
- Post lingually deafened
- Implanted with the CI600 Series (CI612, CI632, CI622, CI624), CI500 Series (CI512, CI532, CI522); Freedom Series (CI24RE(CA), CI24RE(ST), CI422) or N24 Series (CIC3).
- At least 6 months experience with a cochlear hearing implant
- At least 3 months experience with any Nucleus sound processor and SCAN program
- Able to score 30% or more at +15 SNR with CI alone on a sentence in babble 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
- Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedures
- 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, as determined by the Investigator.
- Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation).
Data sourced from ClinicalTrials.gov (NCT05619575). 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.