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

Not Applicable

Completed

• Conditions: Hearing Loss
• Interventions: Device: Phonak's equivalent newly developped power BTE; Device: Equivalent competitor device

• Registration Number: NCT02754843
• Lead Sponsor: Sonova AG

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-16
• Primary Completion: 2016-01
• Status Verified: 2016-04
• Study First Submitted QC: 2016-04-25
• Last Update Submitted: 2016-04-25
• Study First Posted: 2016-04-28
• Last Update Posted: 2016-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Naida Q90-UP	Phonak's equivalent newly developped power BTE	Phonak's commercial power Behind-The-Ear (BTE) device, type 2.
Naida Q90-SP	Phonak's equivalent newly developped power BTE	Phonak's commercial power Behind-The-Ear (BTE) device, type 1.
Naida Q90-SP	Equivalent competitor device	Phonak's commercial power Behind-The-Ear (BTE) device, type 1.
Naida Q90-UP	Equivalent competitor device	Phonak's commercial power Behind-The-Ear (BTE) device, type 2.

Primary Outcome Measures

Name	Time	Method
Speech intelligibility in quiet. Discrimination [%]	One week.	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.
Speech intelligibility in noise. Speech Reception Threshold [dB SNR]	One week.	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.

Secondary Outcome Measures

Name	Time	Method
Phoneme Perception Test, test no. 2.	Four weeks	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.
Phoneme Perception Test, test no. 3.	Four weeks	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.
Diary to describe hearing impressions in everyday life	Six weeks	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.
Phoneme Perception Test, test no. 1.	Four weeks	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.

Trial Locations

Locations (1)

Sonova AG; 🇨🇭 Stäfa, Canton Zürich, Switzerland