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

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ClinicalTrials.gov Identifier: NCT03514758
Recruitment Status : Completed
First Posted : May 2, 2018
Last Update Posted : December 6, 2018
Sponsor:
Collaborator:
Swiss Commission for Technology and Innovation
Information provided by (Responsible Party):
Sonova AG

Tracking Information
First Submitted Date  ICMJE April 20, 2018
First Posted Date  ICMJE May 2, 2018
Last Update Posted Date December 6, 2018
Actual Study Start Date  ICMJE March 26, 2018
Actual Primary Completion Date May 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2018)
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].
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03514758 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation and Optimization of Hearing Devices in 3-D Complex Audio Environments
Official Title  ICMJE Evaluation and Optimization of Hearing Devices in 3-D Complex Audio Environments
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
a group of normal-hearing volunteers
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Ability, Spatial
Intervention  ICMJE Procedure: several virtual 3-D complex audio environments
The focus is a comparison of four virtual 3-D complex audio environments with regard to the sensitivity of hearing aid algorithms.
Study Arms  ICMJE Experimental: normal hearing participants
normal hearing participants with and without hearing aids
Intervention: Procedure: several virtual 3-D complex audio environments
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 20, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 31, 2018
Actual Primary Completion Date May 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03514758
Other Study ID Numbers  ICMJE 2017-02051
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sonova AG
Study Sponsor  ICMJE Sonova AG
Collaborators  ICMJE Swiss Commission for Technology and Innovation
Investigators  ICMJE
Principal Investigator: Norbert Dillier, Professor University Hospital, Zürich
PRS Account Sonova AG
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP