Evaluation of a Binaural Beamformer (StereoZoom) in a Virtual Acoustic Environment and in Real Life

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Brief Title

Evaluation of a Binaural Beamformer (StereoZoom) in a Virtual Acoustic Environment and in Real Life

Official Title

Evaluation of a Binaural Beamformer (StereoZoom) in a Virtual Acoustic Environment and in Real Life

Brief Summary

      The goal of the study is to determine the benefit in speech intelligibility of the BBF and
      the MBF compared to an omni-directional microphone in different noise conditions. Secondary
      objective is to determine if there is a subjective preference for one of the microphone
      settings in different noise conditions.
    

Detailed Description

      Study participants will be invited for two appointments. In the first appointment test will
      be performed inside the lab (lab measurements) and outside the lab (real life measurements)
      and in the second appointment test will be performed in the lab. In between appointments
      participants are asked to try the Naida CI Q90 at home and in their familiar surroundings for
      2-4 weeks (home trial).

      Lab measurements:

      The Oldenburg Sentence Test (Wagner et al. 2006) will be used as speech signal to determine
      the speech reception threshold (SRT) for each background noise with an adaptive procedure.
      The overall level of the noise will be held constant while the level of the speech signal
      will be adapted depending on the words understood correctly for each sentence.

      In addition to the objective speech intelligibility measurements the three microphone
      settings will also be assessed subjectively. For each background noise scenario the Oldenburg
      sentences will be presented successively from the frontal loudspeaker. The experimenter will
      switch between two programs on the participant's processor who then compares the two
      different microphone settings of these programs. Three paired comparisons will be performed:
      omni-directional vs. MBF, omni-directional vs. BBF and MBF vs. BBF. The comparisons will be
      made with regards to speech intelligibility, noise suppression and overall preference in each
      situation.

      Real life measurements:

      Even though the results obtained in the lab present a good approximation to real-life
      performance both beam former options should also be tested outside the lab and in everyday
      life. In a guided tour the experimenter will take the study participant to noisy places in
      Zürich, if possible to the same or similar places in which the lab recordings were made. The
      same paired comparisons as in the lab will be performed with the experimenter talking to the
      participant or reading a story aloud.

      Home trial:

      Finally, the study participant should evaluate all three microphone settings for 2-4 weeks
      during activities in their familiar surroundings, i.e. having a conversation with one or more
      persons at home, in the tram, in a restaurant, attending a meeting at work, etc. Subjective
      feedback will be collected in a questionnaire.

      Instead of collecting subjective feedback in paper form the questions can be presented on a
      SmartPhone (Motorola Moto G) screen for those participants able to use a SmartPhone (Motorola
      Moto G). In that way the participant can answer the questions when he finds himself in a
      certain listening situation. Such a solution might be more comfortable than a paper
      questionnaire for some participants. An App for a mobile questionnaire called MobEval already
      exists from Phonak and will be used in this study. Participants will receive loaner
      SmartPhones (Motorola Moto G).
    


Study Type

Observational


Primary Outcome

speech reception thresholds (SRT) assessment with audiological measures

Secondary Outcome

 paired comparisons assessment with scaling

Condition

Sensory Hearing Loss

Intervention

binaural beamformer


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

4

Start Date

September 1, 2015

Completion Date

October 31, 2016

Primary Completion Date

October 31, 2016

Eligibility Criteria

        Inclusion Criteria:

          -  all participants, which signed the Informed Consent (Appendix Informed Consent Form)

          -  severe to profound hearing impairment - bilaterally implanted with either the CII or
             HiRes90k cochlear implant devices

          -  experience with their more recent CI at least three months

          -  usage of the Naida CI sound processor on each ear for at least three months

          -  ability for speech understanding in the presence of competing noise without any
             assistance from lip-reading

          -  score: at least 20% correct for a sentence test delivered with an SNR of +10 dB, or an
             SRT of better (lower) than +15 dB

          -  ability to give subjective feedback in a certain listening situation

          -  first language: German or Swiss-German

          -  if participants are recruited additionally from other clinics, ability to travel to
             Zurich

        Exclusion Criteria:

          -  Acute inflammation or pain in head-/neck area

          -  Dizziness

          -  Age of participants <18 years

          -  Age of participants > 80 years

          -  Any participant who is found to require substantial changes to their standard clinical
             program may be either excluded, or be asked to first get used to the new program
             before returning for the study test session.
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Norbert Dillier, Prof. Dr, , 

Location Countries

Switzerland

Location Countries

Switzerland

Administrative Informations


NCT ID

NCT03361527

Organization ID

ABERC-14-09-01


Responsible Party

Sponsor

Study Sponsor

Advanced Bionics AG


Study Sponsor

Norbert Dillier, Prof. Dr, Principal Investigator, Universitätsspital Zürich, Klinik für ORL


Verification Date

November 2017