Evaluation of New Custom Made Hearing Product Technology and Shell Modification
NCT ID: NCT02545569
Last Updated: 2019-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
25 participants
INTERVENTIONAL
2020-01-06
2020-12-31
Brief Summary
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Detailed Description
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The purpose of the studies is to evaluate the strengths and weaknesses of new custom product development in comparison to existing/old products. The results should promote the custom product development, to provide a maximum of benefit and wearing comfort to the hearing aid user.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
SINGLE
Study Groups
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Hearing Device Type A
In the ear (ITE) hearing aid, 1-3 weeks wearing
hearing aid (MD class IIa) - ITE, BTE, RIC
Hearing aid means any wearable instrument or device designed for, offered for the purpose of, or represented as aiding persons with or compensating for, impaired hearing.
Hearing Device Type B
In the ear (ITE) hearing aid, 1-3 weeks wearing
hearing aid (MD class IIa) - ITE, BTE, RIC
Hearing aid means any wearable instrument or device designed for, offered for the purpose of, or represented as aiding persons with or compensating for, impaired hearing.
Interventions
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hearing aid (MD class IIa) - ITE, BTE, RIC
Hearing aid means any wearable instrument or device designed for, offered for the purpose of, or represented as aiding persons with or compensating for, impaired hearing.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* lnformed Consent as documented by signature (Appendix lnformed Consent Form)
* Ability to fill in a questionnaire conscientious
* Healthy outer ear (w/o previous surgical procedures)
Exclusion Criteria
* 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
* lnability to produce a reliable hearing test result when pure tone audiometry is attempted by the audiologist
* Massively limited dexterity
* Psychological problems
* Central hearing problems
18 Years
99 Years
ALL
Yes
Sponsors
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Phonak AG, Switzerland
INDUSTRY
Responsible Party
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Principal Investigators
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Jana-Kosima Schwarzlos, B.Sc.
Role: PRINCIPAL_INVESTIGATOR
Switzerland, Sonova AG, CH-8712 Staefa, Zurich
Locations
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Sonova AG
Stäfa, Canton of Zurich, Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KEK-ZH-Nr. 2014-0459
Identifier Type: -
Identifier Source: org_study_id
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