Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2019_20

Sonova

Status: Completed

Conditions: Hearing Loss

Treatments: Device: Hearing Aid with NR_3; Device: Hearing Aid with NR_2; Drug: Hearing Aid with NR_4; Device: Hearing Aid with standard Noise Reduction (NR_1)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04018911

Sonova2019_20

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 participants. These sound changing principles are enabled by respective hearing instrument technologies and 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 randomised active comparator clinical evaluation which will be conducted mono centric at Sonova AG Headquarter based in Stäfa

Enrollment: 22 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 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
  • Known central hearing disorders
  • colour blinded

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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22 participants in 4 patient groups

Hearing Aid standard NR_1

Active Comparator group

Description:

Hearing Aid with standard Noise Reduction (NR) serves as reference condition.

Treatment:

Device: Hearing Aid with standard Noise Reduction (NR_1)

Hearing Aid with NR_2

Experimental group

Description:

NR_2: Noise Reduction principle 2

Treatment:

Device: Hearing Aid with NR_2

Hearing Aid with NR_3

Experimental group

Description:

NR_3: Noise Reduction principle 3

Treatment:

Device: Hearing Aid with NR_3

Hearing Aid with NR_4

Experimental group

Description:

NR_4: Noise Reduction principle 4

Treatment:

Drug: Hearing Aid with NR_4