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

NCT06992310 | Not Yet Recruiting DMC

• 1 other identifier: SRF-30177
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

• Own Voice Level

  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.

  3 weeks

Secondary Outcomes (2)

• Interpersonal distance

  3 weeks

• Qualitative interview form

  3 weeks

Study Arms (3)

Hearing aid standard NR_1

ACTIVE COMPARATOR

Hearing Aid with standard noise reduction (NR) serves as reference condition

Device: Hearing Aid with standard noise reduction (NR_1)

Hearing Aid with NR_2

EXPERIMENTAL

NR\_2: Noise reduction principle 2

Device: Hearing Aid with NR_2

Hearing Aid with NR_3

EXPERIMENTAL

NR\_3: Noise reduction principle 3

Device: Hearing Aid with NR_3

Interventions

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 standard NR_1

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_2

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.

Hearing Aid with NR_3

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sebastian Griepentrog: lead

Study Sites (1)

Sonova AG

Stäfa, 8712, Switzerland

Location

MeSH Terms

Conditions

Hearing Loss

Interventions

Hearing Aids

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Wearable Electronic Devices; Electrical Equipment and Supplies; Equipment and Supplies; Sensory Aids

Study Officials

• Josephine Hollenbach

  Sonova AG

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sebastian Griepentrog

CONTACT

004158928; sebastian.griepentrog@sonova.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical studies manager

Model Details: Each participant will be treated with each sound changing principle in a randomized order.

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: May 28, 2025
• Study Start: August 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)