Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application

Sonova

Status: Completed

Conditions: Hearing Loss

Treatments: Device: Phonak Audéo L2M with Sound Processing Principle 3; Device: Phonak Audéo L2M with Sound Processing Principle 1; Device: Phonak Audéo L2M with Sound Processing Principle 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT03780374

Sonova2018_37

Details and patient eligibility

About

A methodical evaluation of novel sound changing principles in CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired. These sound changing principles are enabled by respective hearing instrument algorithms. The aim of the study is to investigate and asses strength and weaknesses of these novel sound changing principles in terms of hearing performance to determine their application in hearing instruments (Phase of development). Both, objective laboratory measurements as well as subjective evaluations in real life environment will be carried out. This will be a controlled, single blinded and randomized active comparator clinical evaluation which will be conducted mono-centric at Sonova AG Headquarter based in Staefa.

Enrollment: 20 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult hearing impaired persons (minimum age: 18 years) with and without experience with) hearing aids
• Healthy outer ear (without previous surgical procedures)
• Ability to fill in a questionnaire conscientiously
• Informed Consent as documented by signature

Exclusion criteria

• Contraindications to the medical device 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
• Known central hearing disorders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

20 participants in 3 patient groups

Sound Processing Principle 1

Active Comparator group

Description:

Sound Processing Principle 1 will be applied in the hearing aid.

Treatment:

Device: Phonak Audéo L2M with Sound Processing Principle 1

Sound Processing Principle 2

Experimental group

Description:

Sound Processing Principle 2 will be applied in the hearing aid.

Treatment:

Device: Phonak Audéo L2M with Sound Processing Principle 2

Sound Processing Principle 3

Experimental group

Description:

Sound Processing Principle 3 will be applied in the hearing aid.

Treatment:

Device: Phonak Audéo L2M with Sound Processing Principle 3