Exploration of the Functional Effect of Different Hearing Aid Noise Reduction Algorithms in an Ecologically Valid Conversational Situation

Sebastian Griepentrog

Status: Begins enrollment in 1 month

Conditions: Hearing Loss

Treatments: Device: Hearing Aid with NR_3; Device: Hearing Aid with standard noise reduction (NR_1); Device: Hearing Aid with NR_2

Study type: Interventional

Funder types: Industry

Identifiers

NCT06992310

SRF-30177

Details and patient eligibility

About

A methodical evaluation of 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). Objective laboratory measurements as well as subjective ratings 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 Stäfa.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Good written and spoken German language skills
• No suffering from any speech disorders
• Experienced hearing aid user (min. 6 months)
• Ability to stand and walk during the experiment
• Ability to fill in a questionnaire conscientiously
• Ability to produce a reliable hearing test result
• Ability to describe listening experiences/impressions
• The audiogram is in the fitting range of the hearing aid
• The audiogram is in the range of mild to moderate hearing losses (N2 - N4)
• Hearing loss in both ears
• Informed consent form

Exclusion criteria

• Contraindications to the medical device
• Unaidable hearing loss in one or both ears
• Acute tinnitus (in either one ear and occurrence for less than 3 months)
• Anatomical deformity of one or both ears
• Single-sided deafness
• Unwillingness to wear the investigational device during the investigational visits
• Active pacemaker implant
• Ear canals are too narrow to take ear impressions
• Ear canals are too narrow for the use of customized earpieces
• Uncomfortable loudness threshold less than 80 dB for at least one measured frequency
• Known hypersensitivity or allergy against synthetic materials
• Acute symptoms of vertigo or dizziness
• Reported Parkinson's disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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15 participants in 3 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