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

Launched by COCHLEAR · Jan 31, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at two different methods for programming cochlear implants, which are devices that help people with severe hearing loss. The goal is to see which method works better in helping people hear more clearly after they receive their implants. If you or a loved one has received a cochlear implant from the specified series and are between 18 years old and above, you might be eligible to participate in this study.

Participants will need to be able to communicate well in the language used for the study and agree to follow the trial's requirements. During the trial, you can expect to help researchers understand how to improve cochlear implant programming, which could lead to better outcomes for future users. It’s important to note that some factors, such as certain health conditions or being involved in other clinical studies recently, could prevent someone from participating. If you're interested, it’s a great opportunity to contribute to advancements in hearing technology!

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Aged 18 years or older (no upper age limit).
• • 2. Post-lingually deafened defined as severe or greater sensorineural hearing loss onset after the age of 2 years as reported by the subject
• • 3. Unilaterally implanted with the CI600 Series (CI612, CI622, CI632) or CI500 series (CI512, CI522, CI532) cochlear implant.
• • 4. Fluent speaker in the language used to assess speech perception performance, as determined by the investigator.
• • 5. Willingness to participate in and comply with all requirements of the protocol.
• • 6. Willing and able to provide written informed consent
• Exclusion Criteria:
• • 1. Score below 3 on the screening subset of questions from the Mobile Device Proficiency Questionnaire.
• • 2. Subject who will be programmed with an acoustic component in the implanted ear.
• • 3. 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.
• • 4. Diagnosis of auditory neuropathy.
• • 5. Additional health factors, known to the investigator, that would prevent or restrict participation in the evaluations, including significant visual impairment and/or dexterity issues.
• • 6. Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
• • 7. Investigator site personnel directly affiliated with this study and/or their immediate families: immediate family is defined as a spouse, parent, child, or sibling.
• • 8. Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this investigation.
• • 9. 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). -

Trial Officials