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Evaluation of Frequency Lowering Technique

Primary Purpose

Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
hearing aid NaidaUP
hearing aid NaidaSP
Sponsored by
Phonak AG, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hearing Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hoerzentrum Oldenburg

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

hearing aid NaidaUP

hearing aid NaidaSP

Arm Description

Within subject design: compare frequency lowering one with frequency lowering two.

Within subject design: compare frequency lowering one with frequency lowering two.

Outcomes

Primary Outcome Measures

Audibility improvement (Delta of dB SPL thresholds) of high frequency sounds measured with a Phoneme Perception Test.

Secondary Outcome Measures

Full Information

First Posted
November 3, 2014
Last Updated
September 20, 2017
Sponsor
Phonak AG, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT02303210
Brief Title
Evaluation of Frequency Lowering Technique
Official Title
Evaluation of Frequency Lowering Technique
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Phonak AG, Switzerland

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to examine two frequency lowering techniques in case of audibility, recognition, distinction, discriminability and sound quality.
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.

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
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
hearing aid NaidaUP
Arm Type
Other
Arm Description
Within subject design: compare frequency lowering one with frequency lowering two.
Arm Title
hearing aid NaidaSP
Arm Type
Other
Arm Description
Within subject design: compare frequency lowering one with frequency lowering two.
Intervention Type
Device
Intervention Name(s)
hearing aid NaidaUP
Intervention Description
Standard Power Hearing instruments including different frequency lowering techniques
Intervention Type
Device
Intervention Name(s)
hearing aid NaidaSP
Intervention Description
Standard Power Hearing instruments including different frequency lowering techniques
Primary Outcome Measure Information:
Title
Audibility improvement (Delta of dB SPL thresholds) of high frequency sounds measured with a Phoneme Perception Test.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia Rehmann, B.Sc.
Organizational Affiliation
Phonak AG
Official's Role
Study Chair
Facility Information:
Facility Name
Hoerzentrum Oldenburg
City
Oldenburg
State/Province
Niedersachsen
ZIP/Postal Code
26129
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
National Regulations do not require to share data,

Learn more about this trial

Evaluation of Frequency Lowering Technique

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