Evaluation and Optimization of Hearing Devices in 3-D Complex Audio Environments Study 3 (HEAR3D_CE3)

Ability, Spatial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04180254
• Other study ID #: 2017-02051-3
• Status: Completed
• Phase: N/A
• Start date: November 18, 2019
• Est. completion date: January 31, 2020

Study information

• Verified date: September 2020
• 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: 45
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Participants fulfilling any of the following inclusion criteria are eligible for the study:

• Adult persons (minimum age: 18 years)

• Healthy outer ear (without previous surgical procedures, except cochlear implantation)

• Ability to fill in a questionnaire conscientiously

• Informed Consent as documented by signature

Normal hearing participants

• Adult persons with audiometric normal hearing thresholds

Hearing impaired participants

• Adult hearing impaired persons with and without (experience with) hearing aids

• Adult hearing impaired persons with cochlear implant(s)

The presence of any one of the following exclusion criteria will lead to exclusion of the participant:

• 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:
• Effect of several processing on the auditory distance perception
The focus is a comparison of hearing instrument algorithms on the auditory distance perception

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 (4)

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

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 Nov 25. — 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	Success rate of the distance discrimination	Participants are asked whether an audio stimulus is closer or further at the end of the stimulus than at its beginning. The success rate is measured as a function of the test conditions.	8 weeks

External Links

•   Link the the previous part of the study