Automatic Sound Management 3.0 in a Single-unit Audio Processor

Completed

• Conditions: Cochlear Implants

• Registration Number: NCT04918654
• Lead Sponsor: MED-EL Elektromedizinische Geräte GesmbH

Brief Summary

Cochlear implants are routine treatment for people with severe hearing loss. This study tests the RONDO 3, MED-EL's newest single-unit audio processor which comes with new features (Beamformer, Wind-Noise reduction, Ambient noise reduction, Transient noise reduction, Adaptive intelligence).

Detailed Description

MED-EL Cochlear Implants (CI) provide auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing-impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition. Front-end processing of acoustic signals picked up by the audio processor is routinely applied to provide optimal hearing performance under varying listening conditions. Automatic Sound Management (ASM) was introduced by MED-EL with the TEMPO+ audio processor and provided advanced compression and automatic gain management. With the SONNET audio processor, MED-EL introduced ASM 2.0, which added wind noise reduction and microphone directionality to the front-end processing. With the SONNET 2 audio processor, ASM 3.0 was implemented and the features ambient noise reduction, transient noise reduction and an adaptive intelligence (AI) were added. The RONDO 3 implements now ASM 3.0.

This study investigates the impact of ASM 3.0 as implemented in the RONDO 3 on CI users' speech performance and their subjective quality of hearing.

Study Timeline

• Study First Submitted: 2021-05-31
• Study First Submitted QC: 2021-06-07
• Study First Posted: 2021-06-09
• Study Start: 2021-06-25
• Primary Completion: 2023-12-11
• Study Completion: 2023-12-11
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• A minimum of 18 years old
• Experienced user of a RONDO 3 (≥ 3 months) for the ear to be tested
• Post-lingual onset of severe to profound sensory-neural hearing loss on the ear to be tested
• A minimum of 40% speech recognition in the Freiburg Monosyllables Test in quiet at 65 dB SPL for the ear to be tested (at the last time tested in clinical routine)
• Signed and dated Informed Consent Form (ICF) before the start of any study-specific procedure.

Exclusion criteria

• Lack of compliance with any inclusion criteria
• CI user with contralateral hearing equal to or better than 30 dB (pure-tone average over the following frequencies: 250, 500, 1000, and 2000 Hz)
• Implanted with C40X, or C40C on the ear to be tested
• Implanted with an Auditory Brainstem Implant (ABI) or split electrode array
• Known allergic reactions to components of the investigational medical device (RONDO 3) or the SONNET 2
• Anything that, in the opinion of the Investigator, would (a) place the subject at increased risk, (b) preclude the subject's full compliance with or completion of the study

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Speech in noise	Baseline	Oldenburg Sentence Test in noise (S0 N±90 N180)

Secondary Outcome Measures

Name	Time	Method
User Satisfaction	Baseline	Product-specific questionnaire. The questionnaire is not reporting a single score on a scale (min/max score not applicable).
Speech in noise	Baseline	Oldenburg Sentence Test in noise (S0 N0)
Quality of Hearing	Baseline	Hearing Implant Sound Quality Index (HISQUI). Min score: 16, Max score 133. Higher scores mean a better outcome.
Device Satisfaction	Baseline	Audio Processor Satisfaction Questionnaire. Min score: 0, Max score 10. Higher scores mean a better outcome.

Trial Locations

Locations (1)

MHH - Medizinische Hochschule Hannover; 🇩🇪 Hannover, Germany