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

Hearing Loss Clinical Trial

Official title:

Quality Control of CE-Certified Phonak Hearing Aids

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02740023
• Other study ID #: Sonova2015_03
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: February 2016

Study information

• Verified date: June 2018
• Source: Sonova AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Device:
• Hearing Aid (Phonak Audéo V90-13)
Phonak's Receiver-In-the-Canal (RIC) hearing aid Audéo V90-13 will be fitted to the participants individual Hearing loss.
• Hearing Aid (Successor of Phonak Audéo V90-13)
The successor of Phonak's Receiver-In-the-Canal (RIC) hearing aid Audéo V90-13 will be fitted to the participants individual Hearing loss.

Locations

Country	Name	City	State
Switzerland	Sonova AG	Stäfa	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Sonova AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Initial first fit acceptance (pre-calulation) in lab	The data, serving other pre-specified outcomes are collected within the first lab appointment. The acceptance of the initial first fit will be assessed with the aid of quantitative questions within an interview. The results are points on a scale and open ended (e.g. Question: Please rate the sound quality; Answer scale: bad, poor, fair, good, excellent) . Descriptive statistics will be executed in the form of determining number of answers. 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
Other	Sound quality and listening effort ratings in lab	The data, serving other pre-specified outcomes are collected within the lab appointments. The sound quality and listening effort ratings will be assessed with the aid of the Multi-Stimulus Test with Hidden Reference and Anchor (MUSHRA). The results are quantitative sound quality and listening effort ratings. 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
Primary	Speech intelligibility in percent in a quiet listening situation	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.	One week
Secondary	Speech intelligibility in percent in a noisy listening situation	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.	One week