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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
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.
Study details:
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
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-03-14
Primary completion: 2025-03-31
Study completion finish: 2025-03-31
Study type
OTHER
Phase
NA
Trial ID
NCT05709223
Intervention or treatment
DEVICE: Categorical loudness scaling based fitting using the Nexus Research System.
DEVICE: Behavioural fitting using Custom Sound Suite (CSS 6.3) Software
Conditions
- • Hearing Loss
Find a site
Closest Location:
HEARnet
Research sites nearby
Select from list below to view details:
HEARnet
Carlton, Victoria, Australia
Cochlear Sydney
Sydney, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Participants receiving both Categorical Loudness Scaling Based Fitting and behavioural fitting.
| DEVICE: Categorical loudness scaling based fitting using the Nexus Research System.
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Change in Percentage of correct monosyllabic word scores in quiet (S0) at 50 dB SPL | To determine whether the Loudness Target (LT) MAP provides non-inferior speech understanding in quiet compared to the Behavioural MAP. Percentage of correct monosyllabic word scores in quiet (S0) at 50 dB SPL averaged across the sessions at visit 4 and visit 5. Higher the score better the outcome. | 2 days(In booth testing) |
Change in Adaptive sentence in noise scores (S0N0 test setup) | To determine whether the Loudness Target (LT) MAP provides non-inferior speech understanding in noise compared to the Behavioural MAP. Adaptive sentence in noise scores (S0N0 test setup) averaged across the sessions at visit 4 and visit 5. | 2 days (In booth testing) |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Speech, Spatial and Qualities of Hearing Scale (SSQ12) ratings | To determine whether the LT MAP provides non-inferior speech understanding, sound quality and spatial hearing performance subjective ratings in daily life compared to the Behavioural MAP. The SSQ-12 is comprised of 12 items using the response format on a scale from 0 to 10, were 0 equals no ability and 10 equals perfect ability. These are divided into three sub-scales and the questions 1-5 are from the speech sub-scale, 6-8 from the spatial, and 9-12 from the qualities sub-scale. The three sub-scales are the average of the questions within. A 'not applicable' option is given for each item. The change between LT to Behavioural MAP is then calculated and the theoretical score could vary between -10 to + 10. The higher the score the better benefit and positive score indicates improved hearing, a negative value an impaired hearing. | 4 weeks |
Percentage correct monosyllabic word scores in quiet (S0) at 60 dB SPL | To determine whether the LT MAP provides non-inferior speech understanding in quiet compared to the Behavioural MAP early post activation. | One day (in booth testing) |
Adaptive Digit Triplet Test (DTT) in noise scores | To determine whether the LT MAP provides non-inferior speech understanding in noise compared to the Behavioural MAP early post activation. Digit triplets are presented adaptively at different SNRs to estimate a patient's Speech Reception Threshold for 50%-digit triplet identification and expressed as a dB SNR (SNR50). The SRT is determined at the end of the test. A higher SRT means a worse outcome | One day (in clinic testing) |
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