Skip to main content
OpenTrials
Completed

NCT Number: NCT05286385

CP1150 Sound Processor Speech Perception 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cochlear Sydney

Macquarie Park, New South Wales, 2109, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

CP1150 Sound Processor

Device

Speech perception tests whilst the subject is fitted with the CP1150 Sound Processor

CP1150 NF

Device

Speech perception tests whilst the subject is fitted with the CP1150 modified firmware (the addition of notch filters at 978Hz, 1956Hz, 2934Hz, 3912Hz).

CP1150 + FF

Device

Speech perception tests whilst the subject is fitted with the CP1150 Sound Processor with ForwardFocus.

CP1110

Device

Speech perception tests whilst the subject is fitted with the CP1110 Sound Processor.

Primary outcomes

  1. Speech Perception in Quiet Using an CP1150 Sound Processor

    Time frame: One day (in booth testing)

    Paired difference in percentage CNC Words correct in quiet with the CP1150 Sound Processor and CP1150 Sound Processor with modified firmware.

Secondary outcomes

  1. Speech Perception in Quiet Using CP1150 Sound Processor Using Forward Focus Combined With Standard Microphone Directionality.

    Time frame: One day (in booth testing)

    Paired difference in percentage CNC Words correct in quiet with the CP1150 Sound Processor and CP1150 Sound Processor with forward focus

  2. Speech Perception in Quiet With CP1150 and CP1110 Sound Processors

    Time frame: One day (in booth testing)

    Paired difference in percentage CNC Words correct in quiet with the CP1150 Sound Processor and CP1110 Sound Processor

Sponsors and collaborators

Lead sponsor

Cochlear

Industry

Collaborators

  • Avania

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 18, 2022
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.