Quality Control of CE-Certified Phonak Hearing Aids - 2017_37

Not Applicable

Completed

• Conditions: Hearing Loss, Sensorineural
• Interventions: Device: Phonak Audéo B-Direct; Device: Successor of Phonak Audéo B-Direct

• Registration Number: NCT03379766
• 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. 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. This is a pre-validation study, investigating optimized algorithms, features and functions. This will be a clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-13
• Study First Submitted QC: 2017-12-19
• Study First Posted: 2017-12-20
• Study Start: 2018-01-08
• Primary Completion: 2018-02-02
• Study Completion: 2018-02-02
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-08
• Last Update Posted: 2018-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Adult hearing impaired persons (minimum age: 18 years) with at least 3 months 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Phonak Audéo B-Direct	Phonak Audéo B-Direct	The Phonak Audéo B-Direct will be fitted to the participants individual hearing loss.
Successor of Phonak Audéo B-Direct	Successor of Phonak Audéo B-Direct	The successor of Phonak Audéo B-Direct will be fitted to the participants individual hearing loss.

Primary Outcome Measures

Name	Time	Method
Spontaneous acceptance of the initial pre-calculation (first fit)	One week	The data, serving as primary outcomes are collected in the first study appointment. The spontaneous acceptance of the initial pre-calculation (also called 'first fit') in regard to loudness and sound quality will be assessed with the aid of a systematic interview in lab.

Secondary Outcome Measures

Name	Time	Method
Listening effort in noisy listening environment	One week	The data, serving as secondary outcomes are collected in the second study appointment. The listening effort in noisy listening environments will be assessed under controlled conditions in lab with the aid of the Adaptive Categorial Listening Effort Scaling Test (ACALES). The result shows the listening effort on a scale from 'no effort - extreme effort' at different signal to noise ratios.
Speech intelligibility in noisy listening environment	One week	The data, serving as secondary outcomes are collected in the third study appointment. The speech intelligibility in noise will be assessed with the aid of the german Oldenburg sentence test (OLSA) under controlled conditions in lab. The result is the signal to noise ratio in dB (dB SNR).

Trial Locations

Locations (1)

Sonova AG; 🇨🇭 Stäfa, Zürich, Switzerland