Evaluation of Frequency Lowering Technique

September 20, 2017 updated by: Phonak AG, Switzerland
The purpose of this study is to examine two frequency lowering techniques in case of audibility, recognition, distinction, discriminability and sound quality.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a controlled, single blinded and randomised comparative study which is conducted monocentric at Hoerzentrum Oldenburg, Germany. The focus is to test two frequency lowering techniques with an amount of 30 moderate to severe, symmetrically sensorineural hearing impaired adult subjects. The subjects, all of them native German speakers, individually conduct a number of laboratory standard tests and home trials (questionnaires) during 6 months including seven appointments of 2 hours.

Study Type

Interventional

Enrollment (Actual)

30

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

  • Germany
    • Niedersachsen
      • Oldenburg, Niedersachsen, Germany, 26129
        • Hoerzentrum Oldenburg

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • female and male adults (>18 years old)
  • mild to severe Hearing Loss
  • symmetric Hearing Loss
  • german native speakers

Exclusion Criteria:

  • persons who are not able to attend multiple appointments
  • persons who are not able to handle a hearing aid
  • persons with a mental handicap
  • persons with limited access to multiple hearing situations
  • persons with psychological disease
  • no acclimatization to hearing aids

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: hearing aid NaidaUP
Within subject design: compare frequency lowering one with frequency lowering two.
Device: hearing aid NaidaUP
Standard Power Hearing instruments including different frequency lowering techniques
Other: hearing aid NaidaSP
Within subject design: compare frequency lowering one with frequency lowering two.
Device: hearing aid NaidaSP
Standard Power Hearing instruments including different frequency lowering techniques

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Audibility improvement (Delta of dB SPL thresholds) of high frequency sounds measured with a Phoneme Perception Test.
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Phonak AG, Switzerland

Investigators

  • Study Chair: Julia Rehmann, B.Sc., Phonak 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

December 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

November 3, 2014

First Submitted That Met QC Criteria

November 24, 2014

First Posted (Estimate)

November 27, 2014

Study Record Updates

Last Update Posted (Actual)

September 25, 2017

Last Update Submitted That Met QC Criteria

September 20, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 012FrL2612901

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

National Regulations do not require to share data,

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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