Acceptance and Performance of the CP1170 Sound Processor in Experienced Adult Cochlear Implant Recipients

NCT05619575 | Completed Results

• 1 other identifier: CLTD5836
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hearing Impairment

Outcome Measures

Primary Outcomes (1)

• 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)

  Speech perception in noise was measured using the Australian Speech Test In Noise (AUSTIN), which is a test that uses Bamford-Kowal-Bench (BKB)-like target sentences presented in adaptive noise. The goal of the speech perception test in noise was to provide the speech-to-noise ratio for 50% speech intelligibility.

  During a Single Ad-Hoc Visit (between Day 141 - Day 218)

Secondary Outcomes (4)

• 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)

  During a single Ad-Hoc Visit (anytime between Day 141 - Day 218)

• 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)

  During Ad-Hoc Visit (anytime between Day 127 - Day 190)

• Subjective Acceptance and Satisfaction Between the CP1170 Sound Processor and the Subject's Own Processor

  2 weeks

• Paired Difference in Global SSQ12 Scores After Experience With the CP1170 Sound Processor and Own Processor

  During a Single Ad-Hoc Visit (anytime between Day 23 - Day 70)

Study Arms (1)

CP1170 Sound Processor

EXPERIMENTAL

Take home use of CP1170 Sound Processor for 2 weeks followed by in-booth testing of this investigational device. The SCAN 2 FF (automated ForwardFocus On) program will be compared to the SCAN 2 (ForwardFocus Off) program in the CP1170 Sound Processor. This investigational device will also be compared to the CP1150 Sound Processor and participants' own sound processor.

Device: CP1170 Sound Processor; Device: CP1150 Sound Processor

Interventions

CP1170 Sound Processor DEVICE

The CP1170 Sound Processor will be used to determine the hearing performance with the new implementation of ForwardFocus in SCAN 2 (SCAN 2 FF), as assessed by speech perception in noise.

CP1170 Sound Processor

CP1150 Sound Processor DEVICE

Active comparator off-the-ear sound processor.

CP1170 Sound Processor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cochlear: lead
• Avania: collaborator

Study Sites (1)

Cochlear Macquarie

Macquarie, Sydney, 2109, Australia

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: PRS Specialist, Clinical Affairs
• Organization: Cochlear

cltd-prs-admin@cochlear.com

+61 2 9428 6555

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: November 17, 2022
• Study Start: December 20, 2022
• Primary Completion: September 7, 2023
• Study Completion: January 10, 2024
• Last Updated: August 22, 2025
• Results First Posted: July 31, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)