NCT03514758|Completed
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Sponsor study identifier
Secondary identifiers
NIH
interventional
20
1 country
1
Study Start
March 26, 2018
Actual (reported)Primary Completion
May 31, 2018
Actual (reported)Study Completion
May 31, 2018
Actual (reported)A methodical evaluation of novel sound changing principles in CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired participants. These sound changing principles are enabled by respective hearing instrument technologies and hearing instrument algorithms. The aim of the study is to investigate and assess strengths and weaknesses of these novel sound changing principles in terms of hearing performance to determine their application in hearing instruments (Phase of development). Both, objective laboratory measurements as well as subjective evaluations in real life environment will be carried out. This will be a controlled, single blinded and randomised active comparator clinical evaluation which will be conducted mono centric at the University Hospital of Zürich.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 31, 2018
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 26, 2018
Actual (reported)April 20, 2018
Actual (reported)May 2, 2018
Actual (reported)May 31, 2018
Actual (reported)May 31, 2018
Actual (reported)Head movements measured with head tracker
The participant starts the acoustic stimulus, tries to identify the direction of the stimulus as precise as possible and validates the final position. This is interpreted as reaction time with regard to spatial quality in seconds \[s\].
6 weeks
normal hearing participants with and without hearing aids
The focus is a comparison of four virtual 3-D complex audio environments with regard to the sensitivity of hearing aid algorithms.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University Hospital Zurich
Zurich, 8091, Switzerland
Gatehouse S, Noble W. The Speech, Spatial and Qualities of Hearing Scale (SSQ). Int J Audiol. 2004 Feb;43(2):85-99. doi: 10.1080/14992020400050014.
Choisel S, Wickelmaier F. Evaluation of multichannel reproduced sound: scaling auditory attributes underlying listener preference. J Acoust Soc Am. 2007 Jan;121(1):388-400. doi: 10.1121/1.2385043.
Mueller MF, Meisenbacher K, Lai WK, Dillier N. Sound localization with bilateral cochlear implants in noise: how much do head movements contribute to localization? Cochlear Implants Int. 2014 Jan;15(1):36-42. doi: 10.1179/1754762813Y.0000000040. Epub 2013 Nov 25.
Norbert Dillier, Professor
University Hospital, Zürich
20 participants (actual enrollment reported by the registry).
First Submitted
April 20, 2018
First Posted
May 2, 2018
Study Start
March 26, 2018
Actual (reported)Contact the study team to confirm eligibility.
Catic J, Santurette S, Dau T. The role of reverberation-related binaural cues in the externalization of speech. J Acoust Soc Am. 2015 Aug;138(2):1154-67. doi: 10.1121/1.4928132.
Simon LS, Zacharov N, Katz BF. Perceptual attributes for the comparison of head-related transfer functions. J Acoust Soc Am. 2016 Nov;140(5):3623. doi: 10.1121/1.4966115.
Primary Completion
May 31, 2018
Actual (reported)Study Completion
May 31, 2018
Actual (reported)Last Updated
December 6, 2018
Record last verified: 2018-06
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Source: ClinicalTrials.gov.
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