Clinical trial NCT06992310: Exploration of the Functional Effect of Different Hearing Aid Noise Reduction Algorithms in an Ecologically Valid Conversational Situation
Official title: Exploration of the Functional Effect of Different Hearing Aid Noise Reduction Algorithms in an Ecologically Valid Conversational Situation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
First posted: 2025-05-28
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each participant will be treated with each sound changing principle in a randomized order.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Own Voice Level
timeFrame: 3 weeks
Secondary outcomes:
measure: Interpersonal distance
timeFrame: 3 weeks
measure: Qualitative interview form
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Stäfa
country: Switzerland
facility: Sonova AG
Study officials:
affiliation: Sonova AG
name: Josephine Hollenbach
role: PRINCIPAL_INVESTIGATOR
References: