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Evaluation and Optimization of Hearing Devices in 3-D Complex Audio Environments Study 2 (HEAR3D_CE2)

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ClinicalTrials.gov Identifier: NCT03774030
Recruitment Status : Enrolling by invitation
First Posted : December 12, 2018
Last Update Posted : December 12, 2018
Sponsor:
Collaborator:
Swiss Commission for Technology and Innovation
Information provided by (Responsible Party):
Sonova AG

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.

Condition or disease Intervention/treatment Phase
Ability, Spatial Procedure: several virtual 3-D complex audio environments Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: a group of hearing-impaired particpants with mild or severe hearing loss
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation and Optimization of Hearing Devices in 3-D Complex Audio Environments Study 2
Actual Study Start Date : October 9, 2018
Estimated Primary Completion Date : December 14, 2018
Estimated Study Completion Date : December 31, 2018

Arm Intervention/treatment
Experimental: hearing impaired participants
Hearing impaired participants with mild or severe hearing loss
Procedure: several virtual 3-D complex audio environments
The focus is a comparison of 3 hearing aid algorithms in a virtual 3-D complex audio Environment.




Primary Outcome Measures :
  1. 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].



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult persons (minimum age: 18 years) with Hearing loss
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03774030


Locations
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Switzerland
University Hospital Zurich
Zürich, Switzerland, 8091
Sponsors and Collaborators
Sonova AG
Swiss Commission for Technology and Innovation
Investigators
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Principal Investigator: Norbert Dillier, Professor University Hospital