Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
20 participants
OBSERVATIONAL
2019-04-01
2020-03-05
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Subjects
Adult unilateral MED-EL Cochlear implant users (≥ 6 months), with post-lingual, severe to profound sensory-neural hearing loss.
Audio processor SONNET
AI - N/A, WNR - Mild, Beam-former - NAT, AGC Compression - 3:1, AGC Sensitivity - 75%, ANR - N/A, TNR - N/A
SONNET 2: Configuration 1
AI - Off, WNR - Mild, Beam-former - NAT, AGC Compression - 3:1, AGC Sensitivity - 75%, ANR - Mild, TNR - Mild
SONNET 2: Configuration 2
AI - Off, WNR - Mild, Beam-former - NAT, AGC Compression - 3:1, AGC Sensitivity - 75%, ANR - Strong, TNR - Strong
SONNET 2: Configuration 3
AI - Mild, WNR - Mild, Beam-former - Auto (NAT), AGC Compression - 3:1, AGC Sensitivity - 75%, ANR - Auto (Off-Mild), TNR - Auto (Off-Mild)
SONNET 2: Configuration 4
AI - Strong, WNR - Strong, Beam-former - Auto (OMNI-ABF), AGC Compression - 3:1, AGC Sensitivity - 75%, ANR - Auto (Off-Strong), TNR - Auto (Off-Strong)
SONNET 2: OPUS 2 configuration
AI - Off, WNR - Off, Beam-former - OMNI, AGC Compression - 3:1, AGC Sensitivity - 75%, ANR - N/A, TNR - N/A
SONNET 2: SONNET configuration
AI - Off, WNR - Mild, Beam-former - NAT, AGC Compression - 3:1, AGC Sensitivity - 75%, ANR - N/A, TNR - N/A
Interventions
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Audio processor SONNET
AI - N/A, WNR - Mild, Beam-former - NAT, AGC Compression - 3:1, AGC Sensitivity - 75%, ANR - N/A, TNR - N/A
SONNET 2: Configuration 1
AI - Off, WNR - Mild, Beam-former - NAT, AGC Compression - 3:1, AGC Sensitivity - 75%, ANR - Mild, TNR - Mild
SONNET 2: Configuration 2
AI - Off, WNR - Mild, Beam-former - NAT, AGC Compression - 3:1, AGC Sensitivity - 75%, ANR - Strong, TNR - Strong
SONNET 2: Configuration 3
AI - Mild, WNR - Mild, Beam-former - Auto (NAT), AGC Compression - 3:1, AGC Sensitivity - 75%, ANR - Auto (Off-Mild), TNR - Auto (Off-Mild)
SONNET 2: Configuration 4
AI - Strong, WNR - Strong, Beam-former - Auto (OMNI-ABF), AGC Compression - 3:1, AGC Sensitivity - 75%, ANR - Auto (Off-Strong), TNR - Auto (Off-Strong)
SONNET 2: OPUS 2 configuration
AI - Off, WNR - Off, Beam-former - OMNI, AGC Compression - 3:1, AGC Sensitivity - 75%, ANR - N/A, TNR - N/A
SONNET 2: SONNET configuration
AI - Off, WNR - Mild, Beam-former - NAT, AGC Compression - 3:1, AGC Sensitivity - 75%, ANR - N/A, TNR - N/A
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* 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
18 Years
ALL
No
Sponsors
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MED-EL Elektromedizinische Geräte GesmbH
INDUSTRY
Responsible Party
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Locations
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Klinik und Poliklinik für Hals-, Nasen- und Ohrenkrankheiten, plastische und ästhetische Operationen
Würzburg, Bavaria, Germany
Countries
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References
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Kurz A, Rak K, Hagen R. Improved performance with automatic sound management 3 in the MED-EL SONNET 2 cochlear implant audio processor. PLoS One. 2022 Sep 15;17(9):e0274446. doi: 10.1371/journal.pone.0274446. eCollection 2022.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Results of the study, published in an article
Other Identifiers
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MED-EL_CRD_2017_06
Identifier Type: -
Identifier Source: org_study_id
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