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

Sonova AG12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Hearing Loss

Interventions

Hearing Aid (Phonak Audéo V90-13)DEVICE

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)DEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Sonova AG

Stäfa, Canton of Zurich, Switzerland

Outcomes

Primary Outcomes

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.

Time frame: One week

Secondary Outcomes

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.

Time frame: One week

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.