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OpenTrials
Completed

NCT Number: NCT06138665

Evaluation of a New Noise Reduction Strategy in Hearing Aids

The goal of this exploratory interventional study is to evaluate a new hearing aid noise-reduction strategy in experienced hearing aid users, compared to currently available strategies. The primary objective is to measure speech in noise performance with a new strategy and compare to the performance with currently available strategies via a coordinate response measure task.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Phonak Audiology Research Center

Aurora, Illinois, 60504, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • bilateral and symmetrical severe hearing loss
  • experienced hearing aid user 6 months+ hearing aid use
  • good understanding of English language
  • able and willing to wear RIC style hearing aids with custom earpieces

Exclusion criteria

  • unilateral hearing loss
  • mild hearing loss
  • inability to follow verbal directions
  • presence of ear infection, middle ear fluid, dizziness, or worsening of hearing loss within last 90 days

Treatment and study plan

Phonak Audeo Infinio Sphere

Device

Experimental device

Hearing aid B

Device

Active comparator device from different manufacturer that is currently available

Hearing aid C

Device

Active comparator device from different manufacturer that is currently available

Primary outcomes

  1. Coordinate Response Measure

    Time frame: 1 day (lab visit 2)

    Test measures speech perception in the presence of 5 competing talkers, presented from 5 speakers located in front of the participant. The talkers are presented sequentially with a brief offset of 1.2 seconds. One of the talkers is the target talker and the participant is instructed to listen for a specific call sign, which identifies the target talker. The participant is prompted to identify the color and number that is subsequently spoken by the target talker. The location of the target talker is randomized from the five locations in the front hemisphere. A score of correctly repeated color and number is calculated and a higher score is better. The dB levels at which the target talker and competing talkers are presented are determined individually for each participant by the Speech in Noise Test, described in Outcome 4.

Secondary outcomes

  1. ACALES (Adaptive Categorical Listening Effort Scaling)

    Time frame: 1 day (lab visit1)

    An adaptive method of measuring subjective listening effort. Three sentences are presented sequentially in noise. The listener rates their subjective effort on a 13-point scale that goes from Effortless (1) to Extremely Effortful (13). There is a 14th point which is labeled "Only Noise" and indicates no speech was heard. After each rating, the volume of the speech adapts. The algorithm is designed to capture the SNR (Signal to Noise Ratio) that includes both the effortless and the extremely effortful rating for an individual. Listeners rate different SNR levels using the scale, for instance, a listener may rate an SNR of -12 dB (where speech is 12 dB softer than the noise) as Very Effortful, or 11 on the scale, while rating a SNR of -2 (where speech is only 2 dB softer than noise) as Effortless or a 1 on the scale. In comparing HA settings, that which has the least negative SNR for a particular rating on the scale indicates less effort.

  2. Subjective Rankings of Each Hearing Aid

    Time frame: 1 day (lab visit 1)

    Participants ranked the three devices on a scale from 1 (worst) to 5 (best) for five characteristics: Noise suppression, overall satisfaction, speech clarity, speech loudness, speech naturalness. For each participant, ranks were assigned to each device based on the rating it received, with 1 being the highest rank and 3 being the lowest rank. The frequency of each rank was then calculated for each device across all raters. Results are displayed in the count of devices in each ranking. No statistical analysis was performed on this measure.

Sponsors and collaborators

Lead sponsor

Sonova AG

Industry

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 18, 2023
Registry last updated
Aug 19, 2026

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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