Quality Control of CE-Certified Phonak Hearing Aids - 2019_34

Hearing Loss Clinical Trial

Official title:

Quality Control of CE-Certified Phonak Hearing Aids - 2019_34

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04187781
• Other study ID #: Sonova2019_34
• Status: Completed
• Phase: N/A
• Start date: November 11, 2019
• Est. completion date: January 17, 2020

Study information

• Verified date: February 2020
• Source: Sonova AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phonak Hearing Devices pass through different development and study phases. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, resulting from the pre-validation studies, they get optimized. Prior to product launch, the Phonak Hearing Systems get reviewed by a final quality control in terms of clinical trials. This is a validation study, investigating improved algorithms, features, functions and wearing comfort. This will be a clinical investigation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

Description:

This study will compare two settings of an external microphone under real life conditions with experienced hearing aid users.

The external microphone streams the signal (e.g. speaker) directly into the hearing instrument (HI).

The subject should rate the devices in the lab and after a hometrial. The comfort, regarding to the loudness and the sound quality will be tested with the two settings at home and in the lab. Also the speech intelligibility will be tested in the lab.

This will be a clinical investigation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: January 17, 2020
• Est. primary completion date: January 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• experienced hearing aid user

• severe hearing loss

• willingness and interest in testing an external microphone healthy outer ear

• willingness to wear behind the ear hearing aids

• Informed Consent as documented by signature

Exclusion Criteria:

• the audiogram is not in the fitting range of the intended hearing aid

• limited mobility and not in the position to attend weekly appointments in Stäfa (Switzerland)

• participant is not able to describe experiences and hearing impressions

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Device:
• external microphone
External microphone is developed for direct transmission of speech into the hearing aids for better speech intelligibility, especially in noise.

Locations

Country	Name	City	State
Switzerland	Sonova AG	Stäfa

Sponsors (1)

Lead Sponsor	Collaborator
Sonova AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rating of the subjective comfort for the old and the new setting	Rating of the comfort, regarding to the loudness, with the old and the new setting of the external microphone (%)	6 weeks
Secondary	Evaluation of the speech intelligibility in noise	Another Outcome measure of this study is the Evaluation of speech understanding in noise of the device with the old setting and the new setting. Speech understanding in noise will be evaluated with an objective and validated test procedure, the Outcome measure will be the speech intelligibility in %.	2 weeks
Secondary	Subjective Sound Quality rating	The secondary Outcome measure of this study is the Evaluation of the perceived Sound Quality (rated via subjective satisfaction rating) of the signal with the old setting, compared to the new setting of the external microphone.	6 weeks
Secondary	Subjective rating of natural sounds	The subject should rate in the hometrial how natural environmental sounds are with the hearing aids.	6 weeks