Quality Control of CE-Certified Phonak Hearing Aids - 2016_05

Hearing Loss Clinical Trial

Official title:

Quality Control of CE-Certified Phonak Hearing Aids

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02951247
• Other study ID #: Sonova2016_05
• Status: Completed
• Phase: N/A
• First received: October 26, 2016
• Last updated: February 28, 2017
• Start date: November 8, 2016
• Est. completion date: February 20, 2017

Study information

• Verified date: February 2017
• Source: Sonova AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted on hard of hearing participants to grant quality control prior to product launch. The aim of the investigation series is to ensure zero-defect overall performance of the new hearing systems as well as maximum benefit for the participant with the devices in comparison to previously outstanding Phonak Hearing Systems.

Description:

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. 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, as a result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing Systems undergo a final quality control in terms of clinical trials in the way as planned for this study ("phase of final inspection"). This will be a controlled, single blinded and randomised active comparator clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 20, 2017
• Est. primary completion date: February 20, 2017
• 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 in Stäfa (Switzerland)

• 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
Successor of Phonak Virto V90-10 NW O

Locations

Country	Name	City	State
Switzerland	Sonova AG	Stafa	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-calculation) 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.	Two weeks
Primary	Zero-defect performance in daily life	The data, serving as primary outcomes are collected in a series of home trials taking place between the lab trial appointments. The zero-defect performance in daily life (that means: no interruptions, distortions, artefacts, feedback, system noise or other malfunctions) will be assessed with the aid of quantitative questionnaires. The results are "Yes/No" replies and open-ended.	Four weeks
Secondary	Speech intelligibility in noise as signal to noise ration in dB (dB SNR)	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 Oldenburger sentence test. The result is the signal to noise ratio in dB (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.	Two weeks
Secondary	Visibility	The data, serving as secondary outcomes are collected in a series of lab appointments. The visibility will be assessed with the aid of subjective questionnaires.	Four weeks
Secondary	Wearing Comfort	The data, serving as secondary outcomes are collected in a series of lab appointments. The wearing comfort will be assessed with the aid of subjective questionnaires.	Four weeks