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 (CALOS4)

Cochlear

Status: Completed

Conditions: Hearing Loss

Treatments: Device: Categorical loudness scaling based fitting using the Nexus Research System.; Device: Behavioural fitting using Custom Sound Suite (CSS 6.3) Software

Study type: Interventional

Funder types: Industry

Identifiers

NCT05709223

AI5824

Details and patient eligibility

About

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.

Full description

Firstly, it aims to collect data to investigate if the new fitting method gives a good fit of MAP for newly implanted CI-recipients in terms of performance outcomes, compared to the standard streamlined behavioural fitting after 3 months of use. Secondly, it aims to collect data to further refine the new fitting method beyond what is evaluated within this study.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

17 participants in 1 patient group

Participants receiving both Categorical Loudness Scaling Based Fitting and behavioural fitting.

Experimental group

Description:

Participants will receive a categorical loudness scaling based fitting (Interventional) and behavioural fitting with 4 weeks experience of both MAPS

Treatment:

Device: Behavioural fitting using Custom Sound Suite (CSS 6.3) Software

Device: Categorical loudness scaling based fitting using the Nexus Research System.