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

A Pre-market, Open-label, Within Subject Study, of 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.

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.

Study Overview

• Status: Completed
• Conditions: Hearing Impairment
• Intervention / Treatment: Device: CP1170 Sound Processor; Device: CP1150 Sound Processor

Detailed Description

This investigation is planned to investigate the performance and clinical benefits of features that are new to the CP1170 Sound Processor. This study will build on the evidence previously collected on off-the-ear (OTE) sound processors and ForwardFocus, with particular focus on the acceptance and satisfaction of the automation of ForwardFocus in the CP1170 Sound Processor and associated components in general.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Sydney
    • Macquarie, Sydney, Australia, 2109
      • Cochlear Macquarie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged 18 years or older
2. Post lingually deafened
3. 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).
4. At least 6 months experience with a cochlear hearing implant
5. At least 3 months experience with any Nucleus sound processor and SCAN program
6. Able to score 30% or more at +15 SNR with CI alone on a sentence in babble test
7. Willingness to participate in and to comply with all requirements of the protocol
8. Fluent speaker in English as determined by the investigator
9. Willing and able to provide written informed consent.

Exclusion Criteria:

1. Additional disabilities that would prevent participation in evaluations
2. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedures
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, as determined by the Investigator.
6. 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: CP1170 Sound Processor; 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; 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.; Device: CP1150 Sound Processor; Active comparator off-the-ear sound processor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Speech perception in quiet was measured using the CNC monosyllabic words at 50 dB SPL from S0 position. The goal of speech perception assessment in quiet was to compare % words correct for each of the conditions.	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	Number of participants who were somewhat or very satisfied with the overall sound quality of their SCAN program (SCAN in own sound processor, SCAN 2 FF in CP1170) as indicated through two questionnaires. The CP1170 Questionnaire and Baseline Questionnaire have a 5-point Likert scale for each rating (with the values ranging from: 1 = least favourable option to 3 = Neutral to 5 = most favourable option).	2 weeks
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)	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 (anytime between Day 141 - Day 218)
Paired Difference in Global SSQ12 Scores After Experience With the CP1170 Sound Processor and Own Processor	The SSQ12, which measures subjective hearing performance, is comprised of 12 items using the response format on a scale from 0 to 10, where 0 equals no ability and 10 equals perfect ability. These are divided into three sub-scales and the questions 1-5 are from the speech sub-scale, 6-8 from the spatial, and 9-12 from the qualities sub-scale. The three sub-scales are the average of the questions within. A 'not applicable' option is given for each item. The change from baseline is then calculated and the theoretical score could vary between -10 to +10. The higher the score, the higher the benefit. A positive score indicates improved hearing, and a negative value indicates impaired hearing.	During a Single Ad-Hoc Visit (anytime between Day 23 - Day 70)

Collaborators and Investigators

• Sponsor: Cochlear
• Collaborators: Avania

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2022
• Primary Completion (Actual): September 7, 2023
• Study Completion (Actual): January 10, 2024

Study Registration Dates

• First Submitted: November 9, 2022
• First Submitted That Met QC Criteria: November 9, 2022
• First Posted (Actual): November 17, 2022

Study Record Updates

• Last Update Posted (Actual): August 22, 2025
• Last Update Submitted That Met QC Criteria: August 5, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Hearing Loss; Deafness
• Other Study ID Numbers: CLTD5836

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No