- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03514758
Evaluation and Optimization of Hearing Devices in 3-D Complex Audio Environments
December 5, 2018 updated by: Sonova AG
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Zürich, Switzerland, 8091
- University Hospital Zurich
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: normal hearing participants
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Head movements measured with head tracker
Time Frame: 6 weeks
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Norbert Dillier, Professor, University Hospital, Zürich
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 26, 2018
Primary Completion (Actual)
May 31, 2018
Study Completion (Actual)
May 31, 2018
Study Registration Dates
First Submitted
April 20, 2018
First Submitted That Met QC Criteria
April 20, 2018
First Posted (Actual)
May 2, 2018
Study Record Updates
Last Update Posted (Actual)
December 6, 2018
Last Update Submitted That Met QC Criteria
December 5, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 2017-02051
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ability, Spatial
-
Sonova AGSwiss Commission for Technology and InnovationCompletedAbility, SpatialSwitzerland
-
Sonova AGSwiss Commission for Technology and InnovationCompletedAbility, SpatialSwitzerland
-
Rambam Health Care CampusCompleted
-
Hummel, ChristianeLudwig-Maximilians - University of MunichCompleted
-
Çankırı Karatekin UniversityCompleted
-
Göteborg UniversityVifor PharmaCompletedReading Ability
-
Father Flanagan's Boys' HomeRecruitingSpatial Hearing DevelopmentUnited States
-
Mead Johnson NutritionShanghai Children's Medical CenterCompletedCognitive Ability, GeneralChina
-
Rutgers, The State University of New JerseyRecruitingSpatial NavigationUnited States
-
Sheba Medical CenterBar-Ilan University, IsraelUnknown
Clinical Trials on several virtual 3-D complex audio environments
-
Sonova AGSwiss Commission for Technology and InnovationCompletedAbility, SpatialSwitzerland
-
US Department of Veterans AffairsCompleted
-
Sunnybrook Health Sciences CentreRecruiting
-
University of ValenciaCompletedHealthy | Type 2 Diabetes | Impaired Glucose ToleranceSpain
-
University of ValenciaCompletedHealthy | Insulin SensitivitySpain
-
University of Maryland, BaltimoreUS Department of Veterans AffairsSuspended
-
Columbia UniversityUniversity of California, Irvine; Osteoporosis Center of ArmeniaRecruitingOsteoporosis, PostmenopausalArmenia
-
Washington University School of MedicineWithdrawn
-
AHS Cancer Control AlbertaTerminatedPeripheral Neuropathy in Breast Cancer PatientCanada
-
Treatment and Diagnostic Center of Private Enterprise...delta medical promotions agActive, not recruiting