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NCT Number: NCT06992310

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

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.

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Key information

Conditions

Hearing Loss Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hearing Aid with standard Noise Reduction (NR_1)

Device

Each participant will be fitted with the 3 different noise reduction (sound changing) principles on the same hearing aid, saved to 3 manual programs (ensures exact same hearing loss compensation for each intervention).

Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort.

The active comparator condition is the state of the art Noise Reduction principle to mimic the natural directivity of the outer ear.

Hearing Aid with NR_2

Device

Each participant will be fitted with the 3 different noise reduction (sound changing) principles on the same hearing aid, saved to 3 manual programs (ensures exact same hearing loss compensation for each intervention).

Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort.

The experimental conditions vary in their parametrization to result in different degrees of noise suppression and good speech quality.

Hearing Aid with NR_3

Device

Each participant will be fitted with the 3 different noise reduction (sound changing) principles on the same hearing aid, saved to 3 manual programs (ensures exact same hearing loss compensation for each intervention).

Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort.

The experimental conditions vary in their parametrization to result in different degrees of noise suppression and good speech quality.

Primary outcomes

  1. Own Voice Level

    Time frame: 3 weeks

    Changes to the participants' own voice level (RMS in dB) during a conversation in noise in the laboratory will be recorded in each interventional condition.

Secondary outcomes

  1. Interpersonal distance

    Time frame: 3 weeks

    Changes to the participants' interpersonal distance (in m) during a conversation in noise in the laboratory will be measured in each interventional condition.

  2. Qualitative interview form

    Time frame: 3 weeks

    A qualitative questionnaire with predefined questions to gather individual perceptions regarding the 3 interventional conditions during a conversation in noise in the laboratory. The data collected from this questionnaire are scores on a rating scale from "0" (worst) to "5" (best) in increments of 1.

Study contacts

Contact information is provided by the study sponsor or research team.

Sebastian Griepentrog

CONTACT

[email protected]

004158928 ext. 8676

Sponsors and collaborators

Lead sponsor

Sebastian Griepentrog

Industry

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 28, 2025
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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