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

NCT03361527 | Completed

• 1 other identifier: ABERC-14-09-01
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Sensory Hearing Loss

Outcome Measures

Primary Outcomes (3)

• speech reception thresholds (SRT) assessment with audiological measures (omni)

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

  10 months

• speech reception thresholds (SRT) assessment with audiological measures (BBF)

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

  10 months

• speech reception thresholds (SRT) assessment with audiological measures (MBF)

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

  10 months

Secondary Outcomes (3)

• paired comparisons assessment with scaling (speech intelligibility)

  10 months

• paired comparisons assessment with scaling (noise suppression)

  10 months

• paired comparisons assessment with scaling (overall)

  10 months

Interventions

binaural beamformer OTHER

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

See below

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Advanced Bionics AG: lead

Study Sites (1)

Universitätsspital Zürich, Klinik für ORL

Zurich, 8091, Switzerland

Location

Related Publications (7)

• 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.

  PMID: 24755864 RESULT

• 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.

  PMID: 17069317 RESULT

• 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.

  PMID: 19450437 RESULT

• 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.

  PMID: 22750449 RESULT

• 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.

  PMID: 15341225 RESULT

• 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.

  PMID: 21117762 RESULT

• 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.

  PMID: 17204902 RESULT

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Norbert Dillier, Prof. Dr

  Universitätsspital Zürich, Klinik für ORL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2015
• First Posted: December 5, 2017
• Study Start: September 1, 2015
• Primary Completion: October 31, 2016
• Study Completion: October 31, 2016
• Last Updated: August 23, 2024

Record last verified: 2024-08

Locations

CH (1)