N/A
N=17
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
Hearing Loss
Bottom Line
View on ClinicalTrials.gov: NCT05709223 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Change in Percentage of Correct Monosyllabic Word Scores in Quiet (S0) at 50 dB SPL (Behavioural Fitting Minus Categorical Loudness Scaling Based Fitting) — 35.64; 37.15; -1.52 percentage of words correct
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Categorical loudness scaling based fitting using the research fitting system. (Device); Behavioural fitting using Custom Sound Suite (CSS 6.3) Software (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cochlear
- Primary completion
- Feb 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Percentage of Correct Monosyllabic Word Scores in Quiet (S0) at 50 dB SPL (Behavioural Fitting Minus Categorical Loudness Scaling Based Fitting) |
35.64; 37.15; -1.52 | — |
| PRIMARY Change in Adaptive Sentence in Noise Scores Measured in Decibels (S0N0 Test Setup) (Categorical Loudness Scaling Based Fitting Minus Behavioural Fitting) |
5.73; 6.02; 0.29 | — |
| SECONDARY Speech, Spatial and Qualities of Hearing Scale (SSQ12) Ratings (Behavioural Fitting Minus Categorical Loudness Scaling Based Fitting) |
5.41; 5.32; 0.09 | — |
| SECONDARY Percentage Correct Monosyllabic Word Scores in Quiet (S0) at 60 dB SPL (Behavioural Fitting Minus Categorical Loudness Scaling Based Fitting) |
42.78; 39.22; 3.56 | — |
| SECONDARY Adaptive Digit Triplet Test (DTT) in Noise Scores (Categorical Loudnes Scaling Based Fitting Minus Behavioural Fitting) |
-3.94; -3.95; -0.0006 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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). -
Data sourced from ClinicalTrials.gov (NCT05709223). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.