Front-End Processing 3.0 (FEP3)
Front-End Processing 3.0 - Noise Reduction, Transient Reduction, Scene Classifier
Study Overview
Status
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 new SONNET2 audio processor, ASM 3.0 was implemented and the features ambient noise reduction, transient noise reduction and an adaptive intelligence (AI) were added.
This study investigated the impact of ASM 3.0 as implemented in the SONNET2 on CI users' speech performance and their subjective quality of hearing.
Subjects' speech performance was tested in quiet (Freiburg Monosyllables Test) and noise (OLSA) with the SONNET audio processor and the SONNNET 2 audio processor (OPUS 2 Configuration, SONNET Configuration, SONNET 2 Configurations 1-4). Additionally, quality of hearing with two questionnaires (HISQUI19, SSQ12) was evaluated with the subjects SONNET and the SONNET 2 configurations 1-4. Device handling with the SONNET and the SONNET 2 audio processor was investigated with a questionnaire (APSQ). Additionally, the data logging function of the SONNET2 audio processor was used to investigate differences in the use of the SONNET configuration and the SONNET 2 configurations 1-4. Subjects were asked to rate the SONNET 2 configurations 1-4 against the SONNET configuration with a product-specific SONNET2 questionnaires. Further, subjective sound quality was evaluated in different auditory settings and subjects' subjective listening effort was evaluated using the ACAES test with the SONNET 2 (OPUS configuration, SONNET configuration, SONNET 2 configuration 1&2).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Bayern
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Würzburg, Bayern, Germany, 97080
- Klinik und Poliklinik für Hals-, Nasen- und Ohrenkrankheiten, plastische und ästhetische Operationen
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Subjects
Adult unilateral MED-EL Cochlear implant users (≥ 6 months), with post-lingual, severe to profound sensory-neural hearing loss.
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AI - N/A, WNR - Mild, Beam-former - NAT, AGC Compression - 3:1, AGC Sensitivity - 75%, ANR - N/A, TNR - N/A
Other Names:
AI - Off, WNR - Mild, Beam-former - NAT, AGC Compression - 3:1, AGC Sensitivity - 75%, ANR - Mild, TNR - Mild
AI - Off, WNR - Mild, Beam-former - NAT, AGC Compression - 3:1, AGC Sensitivity - 75%, ANR - Strong, TNR - Strong
AI - Mild, WNR - Mild, Beam-former - Auto (NAT), AGC Compression - 3:1, AGC Sensitivity - 75%, ANR - Auto (Off-Mild), TNR - Auto (Off-Mild)
AI - Strong, WNR - Strong, Beam-former - Auto (OMNI-ABF), AGC Compression - 3:1, AGC Sensitivity - 75%, ANR - Auto (Off-Strong), TNR - Auto (Off-Strong)
AI - Off, WNR - Off, Beam-former - OMNI, AGC Compression - 3:1, AGC Sensitivity - 75%, ANR - N/A, TNR - N/A
AI - Off, WNR - Mild, Beam-former - NAT, AGC Compression - 3:1, AGC Sensitivity - 75%, ANR - N/A, TNR - N/A
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Speech in noise
Time Frame: 8 weeks
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Oldenburg Sentence Test in noise (S0N0)
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8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Speech in noise
Time Frame: 8 weeks
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Oldenburg Sentence Test in noise (S0N0)
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8 weeks
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Speech in quiet
Time Frame: 8 weeks
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Freiburg Monosyllabic test in quiet
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8 weeks
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Speech in noise
Time Frame: 8 weeks
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Oldenburg Sentence Test in noise (S0N0T0)
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8 weeks
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Speech in noise
Time Frame: 8 weeks
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Oldenburg Sentence Test in noise (S0, ±N45, ± N135)
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8 weeks
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Quality of hearing
Time Frame: 8 weeks
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Hearing Implant Sound Quality Index
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8 weeks
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Quality of hearing
Time Frame: 8 weeks
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Questionnaire: The Speech, Spatial and Qualities of Hearing Scale (SSQ12; short version, 12 items) with a scale range 0 (worst) to 10 (best)
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8 weeks
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Device handling
Time Frame: 8 weeks
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Audio Processor Satisfaction Questionnaire (APSQ) with a scale range 0 (worst) to 10 (best)
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8 weeks
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Subjective Ratings
Time Frame: 8 weeks
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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")
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8 weeks
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Subjective Ratings
Time Frame: 8 weeks
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Subjective Sound Quality Rating
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8 weeks
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User Satisfaction
Time Frame: 8 weeks
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A product specific questionnaire will be used to gain user satisfaction on the new audio processor and individual setting preferences
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8 weeks
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Device Use
Time Frame: 8 weeks
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Data Logging
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8 weeks
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Sound Quality and Quality of hearing
Time Frame: 8 weeks
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Hearing Implant Sound Quality Index 19 (HISQUI19) with a 7-point rating scale (never to always)
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8 weeks
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Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MED-EL_CRD_2017_06
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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