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

Not Applicable

Completed

• Conditions: Hearing Loss
• Interventions: Device: Categorical loudness scaling based fitting using the Nexus Research System.; Device: Behavioural fitting using Custom Sound Suite (CSS 6.3) Software

• Registration Number: NCT05709223
• Lead Sponsor: Cochlear

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.

Study Timeline

• Study First Submitted: 2022-12-01
• Study First Submitted QC: 2023-01-31
• Study First Posted: 2023-02-02
• Study Start: 2023-03-14
• Status Verified: 2024-06
• Primary Completion: 2025-02-26
• Study Completion: 2025-02-26
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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). -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants receiving both Categorical Loudness Scaling Based Fitting and behavioural fitting.	Behavioural fitting using Custom Sound Suite (CSS 6.3) Software	Participants will receive a categorical loudness scaling based fitting (Interventional) and behavioural fitting with 4 weeks experience of both MAPS
Participants receiving both Categorical Loudness Scaling Based Fitting and behavioural fitting.	Categorical loudness scaling based fitting using the Nexus Research System.	Participants will receive a categorical loudness scaling based fitting (Interventional) and behavioural fitting with 4 weeks experience of both MAPS

Primary Outcome Measures

Name	Time	Method
Change in Adaptive sentence in noise scores (S0N0 test setup)	2 days (In booth testing)	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.
Change in Percentage of correct monosyllabic word scores in quiet (S0) at 50 dB SPL	2 days(In booth testing)	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.

Secondary Outcome Measures

Name	Time	Method
Adaptive Digit Triplet Test (DTT) in noise scores	One day (in clinic testing)	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
Speech, Spatial and Qualities of Hearing Scale (SSQ12) ratings	4 weeks	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.
Percentage correct monosyllabic word scores in quiet (S0) at 60 dB SPL	One day (in booth testing)	To determine whether the LT MAP provides non-inferior speech understanding in quiet compared to the Behavioural MAP early post activation.

Trial Locations

Locations (4)

Cochlear Americas; 🇺🇸 Lone Tree, Colorado, United States

HEARnet; 🇦🇺 Carlton, Victoria, Australia

Cochlear Sydney; 🇦🇺 Sydney, Australia

Medizinische Hochschule Hannover (MHH); 🇩🇪 Hannover, Germany