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

Hearing Loss, Bilateral or Unilateral Clinical Trial

Official title:

Structured Post Market Clinical Follow-up (PMCF) to Evaluate the Quality of a New Hearing Aid Product Generation.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02298452
• Other study ID #: KEK 2013-0144
• Status: Completed
• Phase: N/A
• First received: November 17, 2014
• Last updated: May 2, 2016
• Start date: May 2013
• Est. completion date: September 2015

Study information

• Verified date: May 2016
• Source: Phonak AG, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 253
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Bilateral
• Hearing Loss, Bilateral or Unilateral

Intervention

Device:
• Hearing aid.
The hearing aid will be fitted to the individual hearing loss of the subject.

Locations

Country	Name	City	State
Switzerland	Phonak AG	Stäfa	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Phonak AG, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference of speech intelligibility between devices based on Quest platform and Venture platform for different hearing aid styles	For the objective measurements in laboratory situation, both a standard German speech sentence test in noise (SRT in dB) and a standard German monosyllable word test in quiet (speech discrimination in percent) are used to compare the speech intelligibility for both platforms. The results of the Venture platform of both tests should be at least the same or better than with the Quest platform.	3 years	No
Secondary	Subjective ratings of speech intelligibility during home trials	For the subjective rating of speech intelligibility, questionnaires are used to compare the current platform Quest with the new platform Venture. The subjective impressions are rated by rating scales (e.g. Speech intelligibility in quiet: everything - most - half - little - nothing).	3 years	No
Secondary	Subjective ratings of sound quality during home trials	For the subjective rating of sound quality, questionnaires are used to compare the current platform Quest with the new platform Venture. The subjective impressions are rated by rating scales (e.g. Sound quality for speech in quiet: good - dull - sharp - thin - echo - scratchy - unclear - noisy).	3 years	No
Secondary	Subjective ratings of usability during home trials	For the subjective rating of usability, questionnaires are used to compare the current platform Quest with the new platform Venture . The subjective impressions are rated by rating scales (e.g. Rating of the opening and closing of the battery door: very easy - easy - neither - difficult - very difficult).	3 years	No