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

Sonova

Status: Completed

Conditions: Hearing Loss

Treatments: Device: Hearing Aid (Phonak Audéo V90-13); Device: Hearing Aid (Successor of Phonak Audéo V90-13)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02740023

Sonova2015_03

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

12 participants in 2 patient groups

Phonak Audéo V90-13

Active Comparator group

Description:

The Phonak Audéo V90-13 will be fitted to the participants individual hearing loss.

Treatment:

Device: Hearing Aid (Phonak Audéo V90-13)

Successor of Phonak Audéo V90-13

Experimental group

Description:

The successor of Phonak Audéo V90-13 will be fitted to the participants individual hearing loss.

Treatment:

Device: Hearing Aid (Successor of Phonak Audéo V90-13)