Back to resultsQuest Sound Recover (SR2) vs. Venture SR2
Primary Purpose
Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
hearing aid
Sponsored by
About this trial
This is an interventional other trial for Hearing Loss
Eligibility Criteria
Inclusion Criteria:
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- Ability to fill in a question conscientious
- Healthy outer ear (w/o previous surgical procedures)
- Sensorineural symmetric hearing loss (HL)
- N4 to N7 (degree of HL)
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 when pure tone audiometry is attempted by the audiologist
- Massively limited dexterity
- Known Psychological problems
- Central hearing problems
Sites / Locations
- Sonova AG
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Intervention group
Test group
Arm Description
Hearing aid
Hearing aid
Outcomes
Primary Outcome Measures
Functional gain
Functional gain is to measure the aided threshold (in dB hearing level [HL]) in free field via loudspeaker.
Phoneme Perception Test
Change of Detection thresholds after 4 weeks hearing instrument wearing time
Functional gain
Functional gain is to measure the aided threshold (in dB hearing level [HL]) in free field via loudspeaker.
Phoneme Perception Test
Change of detection thresholds after 4 weeks hearing instrument wearing time
Secondary Outcome Measures
sound quality ratings
questionnaires
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02895477
Brief Title
Quest Sound Recover (SR2) vs. Venture SR2
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
January 20, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sonova AG
4. Oversight
5. Study Description
Brief Summary
Goal of this study is to determine the benefit of an improved feature on a new hearing aid platform.
To investigate the improvements of this feature is compared on a new and older hearing aid platform. The obtained results will be used for future improvement for this feature. This feature should improve the speech understanding and speech recognition of the hearing aid user.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Hearing aid
Arm Title
Test group
Arm Type
Experimental
Arm Description
Hearing aid
Intervention Type
Device
Intervention Name(s)
hearing aid
Primary Outcome Measure Information:
Title
Functional gain
Description
Functional gain is to measure the aided threshold (in dB hearing level [HL]) in free field via loudspeaker.
Time Frame
after 2 weeks
Title
Phoneme Perception Test
Description
Change of Detection thresholds after 4 weeks hearing instrument wearing time
Time Frame
after 2
Title
Functional gain
Description
Functional gain is to measure the aided threshold (in dB hearing level [HL]) in free field via loudspeaker.
Time Frame
after 8 weeks
Title
Phoneme Perception Test
Description
Change of detection thresholds after 4 weeks hearing instrument wearing time
Time Frame
after 8 weeks
Secondary Outcome Measure Information:
Title
sound quality ratings
Time Frame
after 6 and 12 weeks
Title
questionnaires
Time Frame
after 2, 6, 8 and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Informed Consent as documented by signature (Appendix Informed Consent Form)
Ability to fill in a question conscientious
Healthy outer ear (w/o previous surgical procedures)
Sensorineural symmetric hearing loss (HL)
N4 to N7 (degree of HL)
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 when pure tone audiometry is attempted by the audiologist
Massively limited dexterity
Known Psychological problems
Central hearing problems
Facility Information:
Facility Name
Sonova AG
City
Stäfa
State/Province
Zürich
ZIP/Postal Code
8712
Country
Switzerland
12. IPD Sharing Statement
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Quest Sound Recover (SR2) vs. Venture SR2
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