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Completed

NCT Number: NCT07756970

Speech Perception, Spatial Perception and Satisfaction Outcomes of Fitting Based on Hearing In Noise Ability

Hearing speech in the presence of background noise is a significant challenge for those with hearing loss. Being able to hear speech in noise has been rated as the most sought-after feature in hearing aids by hearing aid users. Our study aims to evaluate the effects of adaptation to hearing test in noise on speech perception, spatial perception and satisfaction in bilateral hearing aid users. The development process of speech understanding in noise in individuals with hearing loss over the age of 50 will be monitored with ACT and ecological-HINT tests. Spatial perception will be assessed with the Speech, Spatial Perception and Hearing Quality (SHRQ) Scale, which is a scale that evaluates the current hearing quality in adults. The hearing aid satisfaction process of the participants will be assessed with the APHAB survey.

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Key information

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Aydın University

Istanbul, Kucukcekmece, 34295, Turkey (Türkiye)

About this study

Hypotheses:

H0: Using ACT in the fitting is not more effective than the traditional fitting method in improving speech understanding performance in noise in hearing aid users.

H1: Using ACT in the fitting is more effective than the traditional fitting method in improving speech understanding performance in noise in hearing aid users.

H0: Using ACT in the fitting is not more effective than the traditional fitting method in improving spatial perception performance in hearing aid users.

H1: Using ACT in the fitting is more effective than the traditional fitting method in improving spatial perception performance in hearing aid users.

H0: Using ACT in the fitting does not increase speech understanding performance in noise in hearing aid users.

H1: Using ACT in the fitting increases speech understanding performance in noise in hearing aid users.

H0: Using ACT in the fitting has no effect on improving spatial perception performance in hearing aid users.

H1: Using ACT in the fitting has an effect on improving spatial perception performance in hearing aid users.

H0: Using ACT in fitting has no effect on increasing hearing aid satisfaction in hearing aid users.

H1: Using ACT in fitting has an effect on increasing hearing aid satisfaction in hearing aid users.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Medium (41-55 dB) / moderate to severe (56-70 dB), sensorineural hearing loss (Goodman, 1965)
  • SDS score between 70-100%
  • Being a bilateral hearing aid user
  • Being a user of Oticon, Philips, Bernafon hearing aids
  • Being between 18-50 years of age
  • Signing an informed consent form

Exclusion criteria

  • Conditions with variable hearing loss such as Meniere's disease, ongoing treatment with ototoxic drugs
  • Complaining with tinnitus
  • Low cognitive capacity: Scoring below 24 on the Standardized Mini Mental Test
  • Not signing an informed consent form

Treatment and study plan

ACT method in fitting

Diagnostic Test

The ACT diagnostic test is a suprathreshold, non-language-specific test that measures an individual's hearing ability in real-world noisy environments to determine the level of assistance needed in noise. The test uses the audiogram shape and levels to ensure the correct stimulus intensity is applied. The ACT test then uses the patient's audiogram to present a suprathreshold stimulus (a siren-like sound) to objectively map their hearing ability in noisy environments. In other words, the audiogram measures quantity, i.e. hearing ability, while the ACT measures the quality of hearing. This makes the ACT a robust assessment that reflects an individual's real-world hearing abilities.

Other names: hearing in noise

Traditional fitting

Diagnostic Test

The control group will be fitted with traditional fittings, and the results will be recorded using the KUİK scale and APHAB survey after fitting. They will be called for a check-up at week 1 and month 1, and fitting and scale assessments will be made, and the results will be recorded. Participants' ability to discriminate in noise with the ACT and Turkish Matrix Test, spatial perception with the KUİK scale, and hearing aid satisfaction with the APHAB survey will be assessed at the beginning and month 1. All findings will be compared and statistically analyzed.

Primary outcomes

  1. Eco-HINT

    Time frame: 1 week and 1 month after hearing aid fitting

    Speech-in-noise performance was assessed using the ecologically valid Hearing in Noise Test (eco-HINT). Speech reception thresholds were measured under aided and unaided listening conditions. Lower scores indicate better speech-in-noise performance.

Secondary outcomes

  1. Speech, Spatial Perception and Hearing Quality Scale

    Time frame: 1 week and 1 month after hearing aid fitting

    The individual who is applied the scale evaluates himself/herself and answers each question between 0 and 10 points. All scores are added up and divided by 49 to obtain the "General KUİK score". The scores under the heading of Speech Perception are added up and divided by 14 to obtain the KA score, the scores under the heading of Spatial Perception are added up and divided by 17 to obtain the UA score, and the scores under the heading of Hearing Quality are added up and divided by 18 to obtain the İK score.

  2. APHAB survey

    Time frame: 1 week and 1 month after hearing aid fitting

    APHAB is a survey that allows us to numerically measure the benefits and satisfaction of individuals with hearing loss from their hearing aids in daily hearing situations. Survey questions are answered according to two different listening situations: "without my hearing aid" and "with my hearing aid".

Other outcomes

  1. Audible Contrast Threshold (ACT)

    Time frame: Time Frame: 1 week and 1 month after hearing aid fitting

    The ACT is a suprathreshold, non-language-specific test that measures an individual's ability to hear in real-world noisy environments to determine the level of assistance needed in noise. ACT values are determined by level of intensity. A normal ACT value is between -4 and +4 dB nCL. 4 to 7 dB nCL indicates mild loss, 7 to 10 dB nCL indicates moderate loss, and 10 to 16 dB nCL indicates profound loss.

Sponsors and collaborators

Lead sponsor

Istanbul Aydın University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 11, 2026
Registry last updated
Aug 11, 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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