Performance of a Hearing Aid Platform Including Different Styles of Hearing Aids

NCT ID: NCT02298452

Last Updated: 2016-05-03

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

253 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The reason for this study is to evaluate a new hearing aid product generation replacing the one on the market. The goal is to evaluate the audiological performance, usability as well as features and functions.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a controlled, single blinded comparative study which is conducted monocentric at Phonak Headquarters in Staefa. The focus is to compare a new hearing aid product generation with the one on the market as well as with competitor devices regarding the audiological performance, usability as well as features and functions with the aid of 382 mild to profound hearing impaired subjects (18-90 yrs). The subjects, all of them native (Swiss) German speakers, individually conduct a number of laboratory standard tests and home trials (questionnaires) during nine weeks including weekly appointments of 2 hours.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hearing Loss, Bilateral or Unilateral

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Hearing aid

172 subjects with a mild hearing loss. 140 subjects with a moderate hearing loss. 70 subjects with a severe/ profound hearing loss.

Group Type OTHER

Hearing aid.

Intervention Type DEVICE

The hearing aid will be fitted to the individual hearing loss of the subject.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hearing aid.

The hearing aid will be fitted to the individual hearing loss of the subject.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* all kinds of hearing loss (sensorineural, conductive, combined)
* all kinds of hearing loss (flat, sloping) which are in the fitting range of the hearing aids
* mother tongue (swiss) german

Exclusion Criteria

Subjects

* with a reduced mobility unable to attend weekly study appointments
* without access to a number of different hearing situations
* with strongly reduced ability to describe auditory impressions and the usage of the hearing aids
* which are uncooperative so that it is not possible to record a valid pure tone audiogram
* with a strongly reduced dexterity
* with psychological problems
* central hearing disorders
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Phonak AG, Switzerland

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Simone Ebbing, B. Sc.

Role: PRINCIPAL_INVESTIGATOR

Phonak AG

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Phonak AG

Stäfa, Canton of Zurich, Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KEK 2013-0144

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.