Evaluation and Optimization of Hearing Devices in 3-D Complex Audio Environments Study 2

Ability, Spatial Clinical Trial

— HEAR3D_CE2  

Official title:

Evaluation and Optimization of Hearing Devices in 3-D Complex Audio Environments Study 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03774030
• Other study ID #: 2017-02051-2
• Status: Completed
• Phase: N/A
• Start date: October 9, 2018
• Est. completion date: January 21, 2019

Study information

• Verified date: May 2019
• Source: Sonova AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 21, 2019
• Est. primary completion date: January 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Adult persons (minimum age: 18 years) with Hearing loss

• Healthy outer ear (without previous surgical procedures)

• Ability to fill in a questionnaire conscientiously

• Informed Consent as documented by signature

Exclusion Criteria:

• Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product

• Limited mobility and not in the position to attend weekly appointments

• Limited ability to describe listening impressions/experiences and the use of the hearing aid

• Inability to produce a reliable hearing test result

• Massively limited dexterity

• Known psychological problems

• Known central hearing disorders

Related Conditions & MeSH terms

• Ability, Spatial

Intervention

Procedure:
• several virtual 3-D complex audio environments
The focus is a comparison of 3 hearing aid algorithms in a virtual 3-D complex audio Environment.

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
Sonova AG	Swiss Commission for Technology and Innovation

Country where clinical trial is conducted

Switzerland, 

References & Publications (5)

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. — View Citation

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. — View Citation

Gatehouse S, Noble W. The Speech, Spatial and Qualities of Hearing Scale (SSQ). Int J Audiol. 2004 Feb;43(2):85-99. — View Citation

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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   link to first part of study