Automatic Sound Management 3.0 in a Single-unit Audio Processor

Cochlear Implants Clinical Trial

— RND3  

Official title:

Automatic Sound Management 3.0 in a Single-unit Audio Processor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04918654
• Other study ID #: RND3_MED-EL_CRD_2020_03
• Status: Completed
• Start date: June 25, 2021
• Est. completion date: December 11, 2023

Study information

• Verified date: March 2024
• Source: MED-EL Elektromedizinische Geräte GesmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 11, 2023
• Est. primary completion date: December 11, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cochlear Implants

Locations

Country	Name	City	State
Germany	MHH - Medizinische Hochschule Hannover	Hannover

Sponsors (2)

Lead Sponsor	Collaborator
MED-EL Elektromedizinische Geräte GesmbH	Hannover Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Speech in noise	Oldenburg Sentence Test in noise (S0 N±90 N180)	Baseline
Secondary	Quality of Hearing	Hearing Implant Sound Quality Index (HISQUI). Min score: 16, Max score 133. Higher scores mean a better outcome.	Baseline
Secondary	Device Satisfaction	Audio Processor Satisfaction Questionnaire. Min score: 0, Max score 10. Higher scores mean a better outcome.	Baseline
Secondary	User Satisfaction	Product-specific questionnaire. The questionnaire is not reporting a single score on a scale (min/max score not applicable).	Baseline
Secondary	Speech in noise	Oldenburg Sentence Test in noise (S0 N±90 N180)	Baseline
Secondary	Speech in noise	Oldenburg Sentence Test in noise (S0 N0)	Baseline