Automatic Sound Management 3.0 in a Single-unit Audio Processor (RND3)

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).

Study Overview

• Status: Completed
• Conditions: Cochlear Implants

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 Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

• Study Contact: Name: Mareike Billinger-Finke, Dr.; Phone Number: 1058 +4366460705; Email: mareike.finke@medel.com

Study Locations

• Germany
  • Hannover, Germany, 30625
    • MHH - Medizinische Hochschule Hannover

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Post-lingually deafened adult cochlear implant users with a MED-EL device.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Study Subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speech in noise	Oldenburg Sentence Test in noise (S0 N±90 N180)	Baseline

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: MED-EL Elektromedizinische Geräte GesmbH
• Collaborators: Hannover Medical School
• Investigators: Principal Investigator: Andreas Büchner, Prof. Dr., Hals-Nasen-Ohrenklinik der Medizinischen Hochschule Hannover

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2021
• Primary Completion (Actual): December 11, 2023
• Study Completion (Actual): December 11, 2023

Study Registration Dates

• First Submitted: May 31, 2021
• First Submitted That Met QC Criteria: June 7, 2021
• First Posted (Actual): June 9, 2021

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: RND3_MED-EL_CRD_2020_03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No