Quality Control of CE-Certified Phonak Hearing Aids - 2017_27

A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted on hard of participants with a hearing loss to grant quality control prior to product launch. The aim of the investigation series is to ensure a stable overall performance of the new hearing systems, a good sound quality during phone calls as well as maximum benefit for the participant with the devices.

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Key information

Conditions

Hearing Loss, Bilateral Sensorineural, Progressive Ear Diseases Hearing Disorders Hearing Loss Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sonova AG

Stäfa, Canton of Zurich, 8712, Switzerland

About this study

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 clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
Smartphone user

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

Treatment and study plan

Line extension of the Phonak Audéo B product family

Device

The line extension of Phonak Audéo B product family will be fitted to the participants individual hearing loss.

Primary outcomes

Stable performance in daily life

Time frame: Three weeks

The data, serving as primary outcomes are collected in a series of home trials, taking place between the lab trial appointments. The stable performance in daily life (that means: no significant interruptions, distortions, artefacts, feedback, system noise or other malfunctions) will be assessed with the aid of quantitative questionnaires. Descriptive statistics will be executed. 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.
Phone call - Sound Quality

Time frame: One week

The data serving as primary outcomes are collected in a lab appointment. The participants will be asked to have a phone call with the investigator in the lab. The sound quality will be subjectively assessed by the participants and additionally by the investigators on given scales. Descriptive statistics will be executed. 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.

Sponsors and collaborators

Lead sponsor

Sonova AG

Industry

Registry information

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: Aug 17, 2017
Registry last updated: Sep 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed