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FEP3: Front-End Processing 3.0

Sponsor
MED-EL Elektromedizinische Geräte GesmbH (Industry)
Overall Status
Completed
CT.gov ID
NCT03861442
Collaborator
(none)
20
Enrollment
1
Location
11.1
Actual Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    20 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Front-End Processing 3.0 - Noise Reduction, Transient Reduction, Scene Classifier
    Actual Study Start Date :
    Apr 1, 2019
    Actual Primary Completion Date :
    Mar 5, 2020
    Actual Study Completion Date :
    Mar 5, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Speech in noise [8 weeks]

      Oldenburg Sentence Test in noise (S0N0)

    Secondary Outcome Measures

    1. Speech in quiet [8 weeks]

      Freiburg Monosyllabic test in quiet

    2. Speech in noise [8 weeks]

      Oldenburg Sentence Test in noise (S0N0)

    3. Speech in noise [8 weeks]

      Oldenburg Sentence Test in noise (S0N0T0)

    4. Speech in noise [8 weeks]

      Oldenburg Sentence Test in noise (S0, ±N45, ± N135)

    5. Quality of hearing [8 weeks]

      Hearing Implant Sound Quality Index

    6. Quality of hearing [8 weeks]

      Questionnaire: The Speech, Spatial and Qualities of Hearing Scale (SSQ12; short version, 12 items) with a scale range 0 (worst) to 10 (best)

    7. Device handling [8 weeks]

      Audio Processor Satisfaction Questionnaire (APSQ) with a scale range 0 (worst) to 10 (best)

    8. Subjective Ratings [8 weeks]

      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")

    9. Subjective Ratings [8 weeks]

      Subjective Sound Quality Rating

    10. User Satisfaction [8 weeks]

      A product specific questionnaire will be used to gain user satisfaction on the new audio processor and individual setting preferences

    11. Device Use [8 weeks]

      Data Logging

    12. Sound Quality and Quality of hearing [8 weeks]

      Hearing Implant Sound Quality Index 19 (HISQUI19) with a 7-point rating scale (never to always)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Klinik und Poliklinik für Hals-, Nasen- und Ohrenkrankheiten, plastische und ästhetische Operationen Würzburg Bayern Germany 97080

    Sponsors and Collaborators

    • MED-EL Elektromedizinische Geräte GesmbH

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    MED-EL Elektromedizinische Geräte GesmbH
    ClinicalTrials.gov Identifier:
    NCT03861442
    Other Study ID Numbers:
    • MED-EL_CRD_2017_06
    First Posted:
    Mar 4, 2019
    Last Update Posted:
    Sep 8, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by MED-EL Elektromedizinische Geräte GesmbH
    front-end features
    speech perception
    patient reported outcome

    Study Results

    No Results Posted as of Sep 8, 2021