Clinical trial: Study of a Signal-processing Algorithm Aiming at Improving Speech-in-noise Intelligibility in Normal-hearing and Hearing-impaired Persons (NCT04775810)

Eligibility criteria:
Inclusion criteria for normal-hearing participants :

          -  consenting to and available for the study

          -  age ≥ 18 years and ≤ 25 years

          -  right-handed

          -  native French speaker

          -  pure-tone air-conduction audiometric thresholds at .5, 1, 2, and 4 kHz all ≤ 20 dB
             hearing loss (HL)

        Exclusion criteria for normal-hearing participants :

          -  score at the Tinnitus Handicap Inventory > 56

          -  uncorrected visual impairment

          -  pregnancy

          -  subject placed under legal authority (guardianship, tutorship)

        Inclusion criteria for hearing-impaired participants :

          -  consenting to and available for the study

          -  age ≥ 55 years

          -  native French speaker

          -  pure-tone air-conduction average hearing thresholds (PTA) for frequencies of .5, 1, 2,
             and 4 kHz ≥ 30 dB HL and ≤ 70 dB HL

          -  right-ear PTA for low frequencies (< 2 kHz) lower than the right-ear PTA for high
             frequencies (> 4 kHz). The difference between the two PTAs must be ≥ 20 dB

          -  the difference between the PTA for frequencies of .5, 1, 2, and 4 kHz (PTA.5-4kHz) in
             the right ear and the left-ear PTA.5-4kHz must be ≤ 10 dB

        Exclusion criteria for hearing-impaired participants :

          -  score at the Tinnitus Handicap Inventory > 56

          -  history of a hearing impairment that was left uncorrected for more than 10 years

          -  uncorrected visual impairment

          -  congenital hearing impairment

          -  Ménière's disease

          -  auditory neuropathy

          -  mixed hearing loss

          -  fluctuating hearing impairment

          -  sudden hearing loss

          -  hearing impairment concomitant with other symptoms (e.g. vertigo)

          -  score at the Montreal Cognitive Assessment (MoCA) < 27

          -  subject placed under legal authority (guardianship, tutorship)
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.


Patient description (medical language): A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear.  Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus.  Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane.  Conduction hearing loss is noted in the left ear.  The remainder of the ear, nose, and throat examination is normal.

Patient description (patient's own words): I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal.

Does the patient match the trial criteria? Contradiction