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Hearing LossFEP3NCT03861442

Front-End Processing 3.0

An observational study of Hearing Loss and Hearing Loss, Sensorineural, run by MED-EL Elektromedizinische Geräte GmbH at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study investigated the impact of Automatic Sound Management 3.0 (i.e. ambient noise reduction, transient noise reduction and an adaptive intelligence) as implemented in the SONNET2 on CI users' speech performance and their subjective quality of hearing and device handling. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Audio processor SONNET, SONNET 2: Configuration 1 and SONNET 2: Configuration 2
Type of treatment
Medical device
How many people
20 participants
Where
1 siteGermany
Study dates
1 Apr 2019to 5 Mar 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Post-lingually deafened adult cochlear implant users with a MED-EL device

Who may be able to join

  • 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
Show all 9Show fewer
  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Klinik und Poliklinik für Hals-, Nasen- und Ohrenkrankheiten, plastische und ästhetische Operationen

    Würzburg, Bavaria, 97080

Other trials in Germany

About this study

Official title: Front-End Processing 3.0 - Noise Reduction, Transient Reduction, Scene Classifier

This study investigated the impact of Automatic Sound Management 3.0 (i.e. ambient noise reduction, transient noise reduction and an adaptive intelligence) as implemented in the SONNET2 on CI users' speech performance and their subjective quality of hearing and device handling.

Read the 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).

Being tested
Audio processor SONNET, SONNET 2: Configuration 1, SONNET 2: Configuration 2, SONNET 2: Configuration 3, SONNET 2: Configuration 4
Keywords
front-end features, speech perception, patient reported outcome, Cochlear implants, post lingual sensorineural hearing loss
Medical subject headings
Hearing Loss, Hearing Loss, Sensorineural, Hearing Loss, Bilateral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Audio processor SONNETDevice

    Also called Default

    AI - N/A, WNR - Mild, Beam-former - NAT, AGC Compression - 3:1, AGC Sensitivity - 75%, ANR - N/A, TNR - N/A

  • SONNET 2: Configuration 1Device

    AI - Off, WNR - Mild, Beam-former - NAT, AGC Compression - 3:1, AGC Sensitivity - 75%, ANR - Mild, TNR - Mild

  • SONNET 2: Configuration 2Device

    AI - Off, WNR - Mild, Beam-former - NAT, AGC Compression - 3:1, AGC Sensitivity - 75%, ANR - Strong, TNR - Strong

  • SONNET 2: Configuration 3Device

    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 4Device

    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 configurationDevice

    AI - Off, WNR - Off, Beam-former - OMNI, AGC Compression - 3:1, AGC Sensitivity - 75%, ANR - N/A, TNR - N/A

  • SONNET 2: SONNET configurationDevice

    AI - Off, WNR - Mild, Beam-former - NAT, AGC Compression - 3:1, AGC Sensitivity - 75%, ANR - N/A, TNR - N/A

Study groups in NCT03861442
Study groupRoleWhat they receive
SubjectsAdult unilateral MED-EL Cochlear implant users (≥ 6 months), with post-lingual, severe to profound sensory-neural hearing loss.
Receives: Device: Audio processor SONNET; Device: SONNET 2: Configuration 1; Device: SONNET 2: Configuration 2; Device: SONNET 2: Configuration 3; Device: SONNET 2: Configuration 4; Device: SONNET 2: OPUS 2 configuration; Device: SONNET 2: SONNET configuration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Speech in noise

    Oldenburg Sentence Test in noise (S0N0)

    Measured: 8 weeks

Secondary outcomes (12)

  1. Speech in quiet

    Freiburg Monosyllabic test in quiet

    Measured: 8 weeks

  2. Speech in noise

    Oldenburg Sentence Test in noise (S0N0)

    Measured: 8 weeks

  3. Speech in noise

    Oldenburg Sentence Test in noise (S0N0T0)

    Measured: 8 weeks

  4. Speech in noise

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

    Measured: 8 weeks

  5. Quality of hearing

    Hearing Implant Sound Quality Index

    Measured: 8 weeks

  6. 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)

    Measured: 8 weeks

  7. Device handling

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

    Measured: 8 weeks

  8. 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")

    Measured: 8 weeks

  9. Subjective Ratings

    Subjective Sound Quality Rating

    Measured: 8 weeks

  10. User Satisfaction

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

    Measured: 8 weeks

  11. Device Use

    Data Logging

    Measured: 8 weeks

  12. Sound Quality and Quality of hearing

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

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2019
  2. Study start1 Apr 2019
  3. Primary completion5 Mar 2020
  4. Study completion5 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03861442
Sponsor's protocol ID
MED-EL_CRD_2017_06
Acronym
FEP3
Status last verified
Jun 2024
First submitted
28 Feb 2019
Last updated
5 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36108069

Questions about this trial

What is this clinical trial studying?

An observational study of Hearing Loss and Hearing Loss, Sensorineural, run by MED-EL Elektromedizinische Geräte GmbH at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Speech in noise (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03861442, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2024.

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