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NCT02303210 Clinical Trial

Evaluation of Frequency Lowering Technique

Hearing Loss Clinical Trial

Official title:
Evaluation of Frequency Lowering Technique

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02303210
Other study ID # 012FrL2612901
Secondary ID
Status Completed
Phase N/A
First received November 3, 2014
Last updated September 20, 2017
Start date December 2014
Est. completion date March 2015

Study information
Verified date September 2017
Source Phonak AG, Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date March 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• hearing aid NaidaUP
Standard Power Hearing instruments including different frequency lowering techniques
• hearing aid NaidaSP
Standard Power Hearing instruments including different frequency lowering techniques

Locations
Country Name City State
Germany Hoerzentrum Oldenburg Oldenburg Niedersachsen

Sponsors (1)
Lead Sponsor Collaborator
Phonak AG, Switzerland

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Audibility improvement (Delta of dB SPL thresholds) of high frequency sounds measured with a Phoneme Perception Test. 6 months
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