Quality Control of CE-Labelled Phonak Hearing Systems (Study Part: Sonova2015-00)

Hearing Loss Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02754843
• Other study ID #: Sonova2015-00
• Status: Completed
• Phase: N/A
• First received: October 16, 2015
• Last updated: April 25, 2016
• Start date: October 2015

Study information

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

Clinical Trial Summary

The purpose of this study, which contains a series of successive study parts, is to methodically evaluate Phonak Hearing Systems on hard of hearing participants to grant quality control prior to each product launch.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Hearing impaired persons with and without (experience with) hearing aids

• Good written and spoken (Swiss) German language skills

• Healthy outer ear (without previous surgical procedures)

• Ability to fill in a questionnaire conscientiously

• Informed Consent as documented by signature

Exclusion Criteria:

• Contraindications to the medical device in this study, e.g. known hypersensitivity or allergy to the investigational product

• Limited mobility and not in the position to attend weekly appointments

• Limited ability to describe listening impressions/experiences and the use of the hearing aid

• Inability to produce a reliable hearing test result

• Massively limited dexterity

• Known psychological problems

• Central hearing disorders

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Device:
• Phonak's equivalent newly developped power BTE

• Equivalent competitor device

Locations

Country	Name	City	State
Switzerland	Sonova AG	Stäfa	Canton Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Sonova AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Speech intelligibility in quiet. Discrimination [%]	The data, serving as primary outcome, are collected in a series of lab appointments. The speech intelligibility in quiet will be assessed with the aid of the German rhyme test "Einsilber-Reimtest nach von Wallenberg und Kollmeier" (WaKo). The result is the speech intelligibility in percent. Descriptive statistics will be executed in the form of determining the median and quartiles. Interference statistics will be executed by applying the appropriate parametric or non-parametric test, depending on the data's distribution. A significance level of 5% is pursued.	One week.	No
Primary	Speech intelligibility in noise. Speech Reception Threshold [dB SNR]	The data, serving as primary outcome, are collected in a series of lab appointments. The speech intelligibility in noise will be assessed with the aid of the German Oldenburger sentence test. The result is the Speech Reception Threshold [dB SNR]. Descriptive statistics will be executed in the form of determining the median and quartiles. Interference statistics will be executed by applying the appropriate parametric or non-parametric test, depending on the data's distribution. A significance level of 5% is pursued.	One week.	No
Secondary	Phoneme Perception Test, test no. 1.	Free field audiometry using narrow band high frequency signals to measure detection thresholds [dB]. Descriptive statistics will be executed in the form of determining the median and quartiles. Interference statistics will be executed by applying the appropriate parametric or non-parametric test, depending on the data's distribution. A significance level of 5% is pursued.	Four weeks	No
Secondary	Phoneme Perception Test, test no. 2.	Free field audiometry using high frequency phonemes to capture their recognition thresholds [dB]. Descriptive statistics will be executed in the form of determining the median and quartiles. Interference statistics will be executed by applying the appropriate parametric or non-parametric test, depending on the data's distribution. A significance level of 5% is pursued.	Four weeks	No
Secondary	Phoneme Perception Test, test no. 3.	Free field audiometry using high frequency phonemes to capture the subjects' distinction capabilities [confusion matrix]. Descriptive statistics will be executed in the form of determining the median and quartiles. Interference statistics will be executed by applying the appropriate parametric or non-parametric test, depending on the data's distribution. A significance level of 5% is pursued.	Four weeks	No
Secondary	Diary to describe hearing impressions in everyday life	Subjects are asked to describe their subjective experiences in different listening situations, in daily life, with the aid of quantitative questionnaires. the results are "Yes/No" replies and open-ended.	Six weeks	No