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Sensory Hearing LossNCT03361527

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

An observational study of Sensory Hearing Loss, run by Advanced Bionics AG at 1 site in Switzerland.

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

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Sensory Hearing Loss
What is being tested?
binaural beamformer
How many people
4 participants
Where
1 siteSwitzerland
Study dates
1 Sep 2015to 31 Oct 2016
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: See below

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Universitätsspital Zürich, Klinik für ORL

    Zurich, 8091

Other trials in Switzerland

About this study

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.

Read the 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 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).

Being tested
binaural beamformer
Medical subject headings
Hearing Loss, Sensorineural

What participants receive

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

  • binaural beamformerOther

    Each study participant will use an Advacned Bionics Naida CI Q90 loaner processor during the course of the study, an Advanced Bionics MyPilot remote control and- if applicable- a SmartPhone. the processors will be programmed with SoundWave and BEPSnet.

What is being measured

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

  1. speech reception thresholds (SRT) assessment with audiological measures (omni)

    The primary study outcome are speech reception thresholds (SRT) measured with omni-directional microphone setting

    Measured: 10 months

  2. speech reception thresholds (SRT) assessment with audiological measures (BBF)

    The primary study outcome are speech reception thresholds (SRT) measured with BBF microphone setting

    Measured: 10 months

  3. speech reception thresholds (SRT) assessment with audiological measures (MBF)

    The primary study outcome are speech reception thresholds (SRT) measured with MBF microphone setting

    Measured: 10 months

Secondary outcomes (3)

  1. paired comparisons assessment with scaling (speech intelligibility)

    The main secondary outcome are paired comparisons which will be performed in the lab and on a guided tour outside the lab. The comparisons will be made with regards to speech intelligibility.

    Measured: 10 months

  2. paired comparisons assessment with scaling (noise suppression)

    The main secondary outcome are paired comparisons which will be performed in the lab and on a guided tour outside the lab. The comparisons will be made with regards to noise suppression.

    Measured: 10 months

  3. paired comparisons assessment with scaling (overall)

    The main secondary outcome are paired comparisons which will be performed in the lab and on a guided tour outside the lab. The comparisons will be made with regards to overall preference in each situation.

    Measured: 10 months

Timeline

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

  1. First posted5 Dec 2017
  2. Study start1 Sep 2015
  3. Primary completion31 Oct 2016
  4. Study completion31 Oct 2016

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
Other
Time perspective
Prospective
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03361527
Sponsor's protocol ID
ABERC-14-09-01
Status last verified
Aug 2024
First submitted
23 Nov 2015
Last updated
23 Aug 2024
Results posted
No
Data monitoring committee
No

Publications

  • Buechner A, Dyballa KH, Hehrmann P, Fredelake S, Lenarz T. Advanced beamformers for cochlear implant users: acute measurement of speech perception in challenging listening conditions. PLoS One. 2014 Apr 22;9(4):e95542. doi: 10.1371/journal.pone.0095542. eCollection 2014.

    PubMed 24755864

  • Chung K, Zeng FG, Acker KN. Effects of directional microphone and adaptive multichannel noise reduction algorithm on cochlear implant performance. J Acoust Soc Am. 2006 Oct;120(4):2216-27. doi: 10.1121/1.2258500.

    PubMed 17069317

  • Chung K, Zeng FG. Using hearing aid adaptive directional microphones to enhance cochlear implant performance. Hear Res. 2009 Apr;250(1-2):27-37. doi: 10.1016/j.heares.2009.01.005. Epub 2009 Jan 22.

    PubMed 19450437

  • Chung K, Nelson L, Teske M. Noise reduction technologies implemented in head-worn preprocessors for improving cochlear implant performance in reverberant noise fields. Hear Res. 2012 Sep;291(1-2):41-51. doi: 10.1016/j.heares.2012.06.003. Epub 2012 Jun 28.

    PubMed 22750449

  • Compton-Conley CL, Neuman AC, Killion MC, Levitt H. Performance of directional microphones for hearing aids: real-world versus simulation. J Am Acad Audiol. 2004 Jun;15(6):440-55. doi: 10.3766/jaaa.15.6.5.

    PubMed 15341225

  • Kokkinakis K, Loizou PC. Multi-microphone adaptive noise reduction strategies for coordinated stimulation in bilateral cochlear implant devices. J Acoust Soc Am. 2010 May;127(5):3136-44. doi: 10.1121/1.3372727.

    PubMed 21117762

  • van der Beek FB, Soede W, Frijns JH. Evaluation of the benefit for cochlear implantees of two assistive directional microphone systems in an artificial diffuse noise situation. Ear Hear. 2007 Feb;28(1):99-110. doi: 10.1097/AUD.0b013e31802d0a55.

    PubMed 17204902

Questions about this trial

What is this clinical trial studying?

An observational study of Sensory Hearing Loss, run by Advanced Bionics AG at 1 site in Switzerland.

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 5 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 23 Aug 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 Switzerland. 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 reception thresholds (SRT) assessment with audiological measures (omni) (time frame: 10 months). The study lists 3 primary outcomes in all. 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 NCT03361527, which also lists 7 linked publications.

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 23 Aug 2024.

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