Comparing the Performance of a Categorical Loudness Scaling Based Fitting With a Behavioural Fitting in Adults With a Nucleus Cochlear Implant 3 Months Post-activation

Completed · Not applicable

Conditions studied: Hearing Loss

In brief

This study aims to collect data in newly implanted cochlear implant-recipients to inform future development of fitting methods to optimally and efficiently program a cochlear implant.

Key facts

Study ID

NCT05709223

Run by

Cochlear

People needed

17

Starts

2023-03-14

Expected to finish

2025-02-26

Last updated by the study team

2026-05-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged 18 years or older (no upper age limit).
• Post-lingually deafened defined as severe or greater sensorineural hearing loss onset after the age of 2 years as reported by the subject
• Unilaterally implanted with the CI600 Series (CI612, CI622, CI632) or CI500 series (CI512, CI522, CI532) cochlear implant.
• Fluent speaker in the language used to assess speech perception performance, as determined by the investigator.
• Willingness to participate in and comply with all requirements of the protocol.
• Willing and able to provide written informed consent

You may not qualify if…

• Score below 3 on the screening subset of questions from the Mobile Device Proficiency Questionnaire.
• Subject who will be programmed with an acoustic component in the implanted ear.
• Pure tone average (average of unaided thresholds at 0.5, 1, 2 and 4 kHz) less than or equal to 30 dB HL and aided word score of more than 80% in the contralateral ear.
• Diagnosis of auditory neuropathy.
• Additional health factors, known to the investigator, that would prevent or restrict participation in the evaluations, including significant visual impairment and/or dexterity issues.
• 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 Organizations or contractors engaged by Cochlear for the purposes of this investigation.
• 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). -

Where it is running

• Cochlear Americas — Lone Tree, Colorado, United States
• Cochlear Sydney — Sydney, Sydney, Australia
• HEARnet — Carlton, Victoria, Australia
• Medizinische Hochschule Hannover (MHH) — Hanover, Hannover, Germany

Full record on ClinicalTrials.gov

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