Quality Control of CE-Certified Phonak Hearing Aids - 2015_03

Not Applicable

Completed

• Conditions: Hearing Loss
• Interventions: Device: Hearing Aid (Phonak Audéo V90-13); Device: Hearing Aid (Successor of Phonak Audéo V90-13)

• Registration Number: NCT02740023
• Lead Sponsor: Sonova AG

Brief Summary

Phonak Hearing Systems pass through different development and study stages. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Primary Completion: 2016-01
• Study Completion: 2016-02
• Study First Submitted: 2016-03-31
• Study First Submitted QC: 2016-04-11
• Study First Posted: 2016-04-15
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-20
• Last Update Posted: 2018-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Adult hearing impaired persons (minimum age: 18 years) with and without (experience with) hearing aids
• Good written and spoken (Swiss) German language skills
• Healthy outer ear
• Ability to fill in a questionnaire (p/eCRF) conscientiously
• Informed Consent as documented by signature

Exclusion Criteria

• Contraindications to the MD 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
Phonak Audéo V90-13	Hearing Aid (Phonak Audéo V90-13)	The Phonak Audéo V90-13 will be fitted to the participants individual hearing loss.
Successor of Phonak Audéo V90-13	Hearing Aid (Successor of Phonak Audéo V90-13)	The successor of Phonak Audéo V90-13 will be fitted to the participants individual hearing loss.

Primary Outcome Measures

Name	Time	Method
Speech intelligibility in percent in a quiet listening situation	One week	The data, serving as primary outcomes 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.

Secondary Outcome Measures

Name	Time	Method
Speech intelligibility in percent in a noisy listening situation	One week	The data, serving as secondary outcomes are collected in a series of lab appointments. The speech intelligibility in noise 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.

Trial Locations

Locations (1)

Sonova AG; 🇨🇭 Stäfa, Zürich, Switzerland