CP1150 Sound Processor Speech Perception Compared With the Next Generation of Signal Processing Technology

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

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.

Study Overview

• Status: Completed
• Conditions: Hearing Impairment, Sensorineural
• Intervention / Treatment: Device: CP1150 Sound Processor; Device: CP1150 (modified firmware); Device: CP1150 + FF; Device: CP1110

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Macquarie Park, New South Wales, Australia, 2109
      • Cochlear Sydney

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NON_RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: CP1150; CP1150 will be used as the comparator device for speech perception testing in quiet.	Device: CP1150 Sound Processor; Speech perception tests whilst the subject is fitted with the CP1150 Sound Processor
EXPERIMENTAL: CP1150 (modified firmware); CP1150 Sound Processor with modified firmware.	Device: CP1150 (modified firmware); Speech perception tests whilst the subject is fitted with the CP1150 modified firmware.
EXPERIMENTAL: CP1150 + FF; CP1150 Sound Processor with ForwardFocus.	Device: CP1150 + FF; Speech perception tests whilst the subject is fitted with the CP1150 Sound Processor with ForwardFocus.
EXPERIMENTAL: CP1110; CP1110 is a BTE Sound Processor.	Device: CP1110; Speech perception tests whilst the subject is fitted with the CP1110 Sound Processor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speech perception in quiet using an OTE Sound Processor	Paired difference in percentage CNC Words correct in quiet with the CP1150 Sound Processor and CP1150 Sound Processor with modified firmware.	One day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speech perception in quiet using an OTE Sound Processor using FF combined with standard microphone directionality	Paired difference in percentage CNC Words correct in quiet with the CP1150 Sound Processor and CP1150 Sound Processor with FF	One day
Speech perception in quiet with CP1150 and CP1110 Sound Processors	Paired difference in percentage CNC Words correct in quiet with the CP1150 Sound Processor and CP1110 Sound Processor	One day

Collaborators and Investigators

• Sponsor: Cochlear
• Collaborators: Avania

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 30, 2022
• Primary Completion (ACTUAL): June 29, 2022
• Study Completion (ACTUAL): June 29, 2022

Study Registration Dates

• First Submitted: February 22, 2022
• First Submitted That Met QC Criteria: March 9, 2022
• First Posted (ACTUAL): March 18, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 7, 2022
• Last Update Submitted That Met QC Criteria: July 6, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Sensorineural
• Other Study ID Numbers: CLTD5818

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