Clinical trial NCT05709223: 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
Official title: Feasibility, Prospective, Within-subject, Interventional Study Comparing the Performance of a Categorical Loudness Scaling Based Fitting With a Behavioural Fitting in Adults With a Nucleus Cochlear Implant in the First 3 Months Post-activation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
Collaborators: name: QbD Clinical
name: Avania
First posted: 2023-02-02
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

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). -

Primary outcomes:
measure: Change in Percentage of correct monosyllabic word scores in quiet (S0) at 50 dB SPL
timeFrame: 2 days(In booth testing)
measure: Change in Adaptive sentence in noise scores (S0N0 test setup)
timeFrame: 2 days (In booth testing)
Secondary outcomes:
measure: Speech, Spatial and Qualities of Hearing Scale (SSQ12) ratings
timeFrame: 4 weeks
measure: Percentage correct monosyllabic word scores in quiet (S0) at 60 dB SPL
timeFrame: One day (in booth testing)
measure: Adaptive Digit Triplet Test (DTT) in noise scores
timeFrame: One day (in clinic testing)
Other outcomes:
Locations:
city: Lone Tree
country: United States
facility: Cochlear Americas
state: Colorado
city: Carlton
country: Australia
facility: HEARnet
state: Victoria
city: Sydney
country: Australia
facility: Cochlear Sydney
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover (MHH)
Study officials:
affiliation: Cochlear
name: Anke Plasmans
role: STUDY_DIRECTOR
References: