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

NCT03514758 | Completed

• 1 other identifier: 2017-02051
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ability, Spatial

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

normal hearing participants

EXPERIMENTAL

normal hearing participants with and without hearing aids

Procedure: several virtual 3-D complex audio environments

Interventions

several virtual 3-D complex audio environments PROCEDURE

The focus is a comparison of four virtual 3-D complex audio environments with regard to the sensitivity of hearing aid algorithms.

normal hearing participants

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult normal hearing persons (minimum age: 18 years)
• Healthy outer ear (without previous surgical procedures)
• Ability to fill in a questionnaire conscientiously
• Informed Consent as documented by signature

You may not qualify if:

• 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

Sponsors & Collaborators

• Sonova AG: lead
• Swiss Commission for Technology and Innovation: collaborator

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

Location

Related Publications (5)

• 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.

  PMID: 15035561 BACKGROUND

• 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.

  PMID: 17297794 BACKGROUND

• 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.

  PMID: 23684420 BACKGROUND

• 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.

  PMID: 26328729 BACKGROUND

• 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.

  PMID: 27908072 BACKGROUND

MeSH Terms

Conditions

Spatial Navigation

Condition Hierarchy (Ancestors)

Spatial Behavior; Behavior

Study Officials

• Norbert Dillier, Professor

  University Hospital, Zürich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: a group of normal-hearing volunteers

Study Record Dates

• First Submitted: April 20, 2018
• First Posted: May 2, 2018
• Study Start: March 26, 2018
• Primary Completion: May 31, 2018
• Study Completion: May 31, 2018
• Last Updated: December 6, 2018

Record last verified: 2018-06

Locations

CH (1)