Quest Sound Recover (SR2) vs. Venture SR2

January 27, 2017 updated by: Sonova AG

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

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

  • Switzerland
    • Zürich
      • Stäfa, Zürich, Switzerland, 8712
        • Sonova AG

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 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Hearing aid
Device: hearing aid
Experimental: Test group
Hearing aid
Device: hearing aid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional gain
Time Frame: after 2 weeks
Functional gain is to measure the aided threshold (in dB hearing level [HL]) in free field via loudspeaker.
after 2 weeks
Phoneme Perception Test
Time Frame: after 2
Change of Detection thresholds after 4 weeks hearing instrument wearing time
after 2
Functional gain
Time Frame: after 8 weeks
Functional gain is to measure the aided threshold (in dB hearing level [HL]) in free field via loudspeaker.
after 8 weeks
Phoneme Perception Test
Time Frame: after 8 weeks
Change of detection thresholds after 4 weeks hearing instrument wearing time
after 8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
sound quality ratings
Time Frame: after 6 and 12 weeks
after 6 and 12 weeks
questionnaires
Time Frame: after 2, 6, 8 and 12 weeks
after 2, 6, 8 and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sonova AG

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

July 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

January 20, 2017

Study Registration Dates

First Submitted

August 29, 2016

First Submitted That Met QC Criteria

September 5, 2016

First Posted (Estimate)

September 9, 2016

Study Record Updates

Last Update Posted (Estimate)

January 30, 2017

Last Update Submitted That Met QC Criteria

January 27, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sonova2016_10

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.

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