Clinical trial NCT04180254: Evaluation and Optimization of Hearing Devices in 3-D Complex Audio Environments Study 3 (HEAR3D_CE3)
Official title: Evaluation and Optimization of Hearing Devices in 3-D Complex Audio Environments Study 3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ability, Spatial
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
Collaborators: name: Swiss Commission for Technology and Innovation
First posted: 2019-11-27
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: a group of normal hearing and hearing-impaired participants
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Success rate of the distance discrimination
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Hospital Zurich
Study officials:
References:
citation: 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.
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.
citation: 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.
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. doi: 10.1121/1.4966115.