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Evaluation of Frequency Lowering Technique

NCT ID: NCT02303210

Last Updated: 2017-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Hearing Loss

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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hearing aid NaidaUP

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

Group Type OTHER

hearing aid NaidaUP

Intervention Type DEVICE

Standard Power Hearing instruments including different frequency lowering techniques

hearing aid NaidaSP

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

Group Type OTHER

hearing aid NaidaSP

Intervention Type DEVICE

Standard Power Hearing instruments including different frequency lowering techniques

Interventions

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hearing aid NaidaUP

Standard Power Hearing instruments including different frequency lowering techniques

Intervention Type DEVICE

hearing aid NaidaSP

Standard Power Hearing instruments including different frequency lowering techniques

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Phonak AG, Switzerland

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julia Rehmann, B.Sc.

Role: STUDY_CHAIR

Phonak AG

Locations

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Hoerzentrum Oldenburg

Oldenburg, Lower Saxony, Germany

Site Status

Countries

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Germany

Other Identifiers

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012FrL2612901

Identifier Type: -

Identifier Source: org_study_id