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Completed

NCT Number: NCT05582408

Evaluation of Novel Noise Reduction Principles in Hearing Instruments

In the study, the speech intelligibility in noise (Outcome) between a novel noise reduction algorithm (Intervention) versus the standard noise reduction (Comparator) will be tested in adults with a N3-N4 hearing loss (Population) using streamed signals via hearing aids.

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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–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hörzentrum Oldenburg gGmbH

Oldenburg, Lower Saxony, 26129, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Minimum age for men: 18 years, minimum age for wom-en: 64 years, hearing aid users,
  • Written and spoken German,
  • Hearing loss range: N3-N4 Hearing loss (sensorineural)
  • Healthy outer ear,
  • Ability to understand and follow the instruction of the in-vestigator
  • Informed consent as documented by signature.

Exclusion criteria

  • Clinical contraindications 1) hearing loss is not within the fitting range of the hearing aid, 2) acute tinnitus, 3) de-formity of the ear (closed ear canal or absence of pinna), and 4) neural hearing loss i.e., retro-cochlear pathologies such as absent / non-viable auditory nerve
  • Pregnant or breastfeeding women
  • Age >85 years
  • known hypersensitivity or allergy,
  • limited mobility and not able to attend the appointments

Treatment and study plan

Measures of Standard Noise Reduction NR1

Device

Each participant will be fitted with the Standard Noise Reduction (NR1)

Measures of Noise Reduction Principle NR2

Device

Each participant will be fitted with the novel Noise Reduction principle NR2 on the same hearing aid

Measure of Noise Reduction Principle NR3

Device

Each participant will be fitted with the novel Noise Reduction principle NR3 on the same hearing aid

Primary outcomes

  1. Difference in speech reception thresholds (SRTs) in noise between novel noise reduction algorithm (NR2) and the standard noise reduction (NR1; Comparator)

    Time frame: 4 weeks

    SRTs are measured with the OLSA test.

Secondary outcomes

  1. Evaluation whether the novel noise reduction algorithm (NR3) provides different SRTs in noisy situation with speech from front compared to the current implemented "standard noise reduction" (NR1; Comparator)

    Time frame: 4 weeks

    SRTs are measured with the OLSA test.

  2. Evaluation of subjectively different sound quality attributes/dimensions of the novel noise reduction algorithms versus standard noise reduction (Comparator)

    Time frame: 4 weeks

    The sound quality ratings will be assessed with the aid of a Multi-Stimulus Test.

Sponsors and collaborators

Lead sponsor

Sonova AG

Industry

Registry information

Official study title

Evaluation of Novel Noise Reduction Principles in Hearing Instruments to Determine Their Applicability.

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 17, 2022
Registry last updated
Nov 17, 2022

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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