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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
17
The research fitting system is used in combination with other devices as part of a hearing implant system. It is intended to create and modify hearing profiles, to monitor the performance of the system and to facilitate firmware updates of the system.
The comparator is the commercially available fitting method (i.e., the behavioural measurement of active channels) using Custom Sound Suite (CSS 6.3) software
Cochlear Americas
Lone Tree, Colorado, United States
Cochlear Sydney
Sydney, Sydney, Australia
HEARnet
Carlton, Victoria, Australia
Medizinische Hochschule Hannover (MHH)
Hanover, Hannover, Germany
Change in Percentage of Correct Monosyllabic Word Scores in Quiet (S0) at 50 dB SPL (Behavioural Fitting Minus Categorical Loudness Scaling Based Fitting)
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. The higher the score, the better the outcome.
Time frame: At visit 4 (week 8) and visit 5 (week 12)
Change in Adaptive Sentence in Noise Scores Measured in Decibels (S0N0 Test Setup) (Categorical Loudness Scaling Based Fitting Minus Behavioural Fitting)
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) are averaged across the sessions at visit 4 and visit 5. Scores are expressed in decibels (dB).
Time frame: At visit 4 (week 8) and visit 5 (week 12)
Speech, Spatial and Qualities of Hearing Scale (SSQ12) Ratings (Behavioural Fitting Minus Categorical Loudness Scaling Based Fitting)
To determine whether the loudness target map provides non-inferior speech understanding, sound quality and spatial hearing performance subjective ratings in daily life compared to the behavioural map. The SSQ12 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 3 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 average SSQ12 scores (on entire questionnaire) for each map type were used. SSQ12 ratings were collected at visit 4 and visit 5. 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 the benefit. A positive score indicates improved hearing, while a negative value indicates impaired hearing.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: At visit 4 (week 8) and visit 5 (week 12)
Percentage Correct Monosyllabic Word Scores in Quiet (S0) at 60 dB SPL (Behavioural Fitting Minus Categorical Loudness Scaling Based Fitting)
To determine whether the LT map provides non-inferior speech understanding in quiet compared to the behavioural map early post activation.
Time frame: Visit 3 (week 4)
Adaptive Digit Triplet Test (DTT) in Noise Scores (Categorical Loudnes Scaling Based Fitting Minus Behavioural Fitting)
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
Time frame: Visit 3 (week 4)