Trial document




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  DRKS00010807

Trial Description

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Title

Bimodal Benefit of Front-end Features

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Trial Acronym

ABIntl-15-11

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The use of frontend features in hearing aids increases the speech understanding in noise and the sound quality, and an enhancement of the acceptable noise in bimodal patients (CI and hearing aid on the contralateral side)

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Brief Summary in Scientific Language

For cochlear implant (CI) as well as hearing aid (HA) users understanding speech in noisy listening conditions remains a challenge. So far, the only effective method to improve the signal-to-noise ratio (SNR) – and thus speech intelligibility – in such conditions is the use of directional microphones. Directional microphones (also called beamformers) attenuate sounds from the back hemisphere and to the side of the listener while maintaining signals from the front so that a speaker in front of the listener becomes easier to understand. Adaptive beamformers are able to adapt their maximal attenuation depending on the position of the noise source. Furthermore, frequency specific attenuation can be achieved which is useful if several noise sources with different frequency characteristics and locations are present. These beamformers have already proven useful in hearing aids for hearing-impaired people (Ricketts and Henry 2002; Bentler et al. 2004; Dillon 2012).
With the launch of the Naída CI Q70 behind-the-ear (BTE) sound processor (SP) Advanced Bionics introduces an adaptive beamformer called UltraZoom for CI users (Geissler et al. 2014) similar to the UltraZoom feature implemented in Phonak hearing aids (e.g. Naida Q90 UP) (Nyffeler 2010). This beamformer should improve speech intelligibility for unilateral, bilateral and bimodal CI and HA users in noisy listening conditions.
In this study the adaptive beamformer UltraZoom, the impulsive noise canceller SoundRelax as well as the noise reduction algorithms ClearVoice or NoiseBlock, respectively, shall be evaluated in bimodal (CI and HA) users to investigate the cooperation between both sides and to find parameterizations for an optimized interaction.

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Organizational Data

  •   DRKS00010807
  •   2016/07/26
  •   [---]*
  •   no
  •   Approved
  •   231/16, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   H91.8 -  Other specified hearing loss
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Interventions/Observational Groups

  •   Bimodal cochlear implants patients (Advanced Bionics CII or HiRes90k, Speechprocessor:Auria, Harmony, Naida CI Q70, Naida CI Q90) with contralateral hearing aid will be enrolled. The benefit of the adaptive Beamformer (Ultrazoom), of the front-end algorithm (ClearVoics/noiseblock) and of the impulive Noise canceller (soundRelax) will be investigated.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Speech understanding in noise will be tested with sentences of OlSa (Oldenburger Satztest) with bimodal restored patients with bimodal frontend features

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Secondary Outcome

Speech understanding of sentences of the OslA test, sound quality and acceptable sound pressure in noise will be evaluated and the use of three differnet front end features in CI and HA.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2016/08/01
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- German mother language
- unilateral CI
* Implantat: Advanced Bionics CII or HiRes90k
* Processor: Auria, Harmony, Naida CI Q70, Naida CI Q90
* minimum of 6 month CI user
- contralateral hearing aid
* minimum of 6 month hearing aid user
- CI hearing with the CI restored ear
* Speech understanding thresholds in 65dB SPL-noise at OlSa ≤ 10dB
- Hearing with the hearing aid restored ear
* Speech understanding with Freiburger Sentence test at 65dB SPL ≥ 20 %

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Exclusion Criteria

kcognitive disabilities

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Addresses

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    • Advanced Bionics AG
    • Ms.  Martina  Brendel 
    • Laubisrütistrasse 28
    • 8712  Stäfa
    • Switzerland
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    • Universitäts-HNO-Klinik Freiburg
    • Mr.  Dr  Thomas  Wesarg 
    • Elsässer Straße 2n
    • 79110  Freiburg
    • Germany
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    • Universitäts-HNO-Klinik Freiburg
    • Mr.  Dr  Thomas  Wesarg 
    • Elsässer Straße 2n
    • 79110  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Advanced Bionics AG
    • Ms.  Martina  Brendel 
    • Laubisrütistrasse 28
    • 8712  Stäfa
    • Switzerland
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.