Front-End Processing 3.0 (FEP3)

Front-End Processing 3.0 - Noise Reduction, Transient Reduction, Scene Classifier

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. With the new SONNET 2 audio processor, ASM 3.0 was implemented and the features noise reduction, transient reduction and an automatic scene classifier were added. This study will investigate the impact of ASM 3.0 as implemented in the SONNET 2 on CI users' speech performance and their subjective quality of hearing.

Study Overview

• Status: Completed
• Conditions: Cochlear Implants

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Germany
  • Bayern
    • Würzburg, Bayern, Germany, 97080
      • Klinik und Poliklinik für Hals-, Nasen- und Ohrenkrankheiten, plastische und ästhetische Operationen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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 (≥ 6 months) of a MED-EL cochlear implant (CI; C40+ and later model)
• Experienced user of a MED-EL SONNET audio processor (≥ 6 months)
• Post-lingual onset of bilateral severe to profound sensory-neural hearing loss
• Unilateral CI user
• A minimum of 10 active electrodes
• A minimum of 40% speech recognition in the Freiburg Monosyllables test in quiet at 65 dB sound pressure level (SPL; at the last time tested)
• Fluent in German (the language of the test centre)
• Signed and dated Informed Consent Form 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 60 dB (PTA measured at 500, 1000, and 2000Hz)
• User with electric-acoustic stimulation (EAS; user of an EAS audio processor)
• Implanted with C40X and C40C
• Implanted with an Auditory Brainstem Implant or Split electrode array
• Known allergic reactions to components of the investigational medical device
• Unstable psychological status
• Anything that, in the opinion of the Investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speech in noise	Oldenburg Sentence Test in noise (S0N0)	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speech in noise	Oldenburg Sentence Test in noise (S0N0)	8 weeks
Speech in quiet	Freiburg Monosyllabic test in quiet	8 weeks
Speech in noise	Oldenburg Sentence Test in noise (S0N0T0)	8 weeks
Speech in noise	Oldenburg Sentence Test in noise (S0, ±N45, ± N135)	8 weeks
Quality of hearing	Hearing Implant Sound Quality Index	8 weeks
Quality of hearing	Questionnaire: The Speech, Spatial and Qualities of Hearing Scale (SSQ12; short version, 12 items) with a scale range 0 (worst) to 10 (best)	8 weeks
Device handling	Audio Processor Satisfaction Questionnaire (APSQ) with a scale range 0 (worst) to 10 (best)	8 weeks
Subjective Ratings	Adaptive CAtegorical Listening Effort Scaling (ACALES); Subjectively perceived listening Effort is evaluated using a 14-step scale contains eight labelled categories (from "effortless" to "extremely strenuous" and "noise only")	8 weeks
Subjective Ratings	Subjective Sound Quality Rating	8 weeks
User Satisfaction	A product specific questionnaire will be used to gain user satisfaction on the new audio processor and individual setting preferences	8 weeks
Device Use	Data Logging	8 weeks
Sound Quality and Quality of hearing	Hearing Implant Sound Quality Index 19 (HISQUI19) with a 7-point rating scale (never to always)	8 weeks

Collaborators and Investigators

• Sponsor: MED-EL Elektromedizinische Geräte GesmbH

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2019
• Primary Completion (ACTUAL): March 5, 2020
• Study Completion (ACTUAL): March 5, 2020

Study Registration Dates

• First Submitted: February 28, 2019
• First Submitted That Met QC Criteria: March 1, 2019
• First Posted (ACTUAL): March 4, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 8, 2021
• Last Update Submitted That Met QC Criteria: September 6, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: patient reported outcome; front-end features; speech perception
• Other Study ID Numbers: MED-EL_CRD_2017_06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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