Phase 2 N=23 FX-322 in Sensorineural Hearing Loss
Sensorineural Hearing Loss
Primary: Number of Participants With Treatment-emergent Adverse Event(s) (TEAEs) — 2; 3; 5; 6 Participants
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Phase 2 N=142 FX-322 in Adults With Acquired Sensorineural Hearing Loss
Hearing Loss, Sensorineural · Noise Induced Hearing Loss · Sudden Hearing Loss
Primary: Word Recognition in Quiet — 14.7; 11.1 Percent of subjects — p=0.525
N/A N=38 Age-related Hearing Loss and Lexical Disorders
Alzheimer Disease · Presbycusis · Lexical Syntactic Disorder
Primary: Link Between Lack of Word and Presbycusis — 38; 38.5; 23; 21.5 score on a scale
Phase 4 N=25 Treating Hearing Loss to Improve Mood and Cognition in Older Adults
Hearing Loss · Depression
Primary: Hamilton Rating Score for Depression (HRSD) — 12.04; 13.86 score on a scale
Phase 2 N=95 FX-322 in Adults With Stable Sensorineural Hearing Loss
Sensorineural Hearing Loss · Noise Induced Hearing Loss · Sudden Sensorineural Hearing Loss
Primary: Word Recognition in Quiet — 23.8; 16.7; 15.8; 18.8 Percent — p=0.068
N/A N=40 Cochlear Implantation in Adults With Asymmetric Hearing Loss Clinical Trial
Hearing Loss
Primary: Change in Poor Ear Alone CNC Monosyllabic Word Understanding in Quiet — 0.09; 0.53; 0.44 percentage of words correct — p=<0.001
N/A N=129 Hearing Loss Prevention for Veterans
Hearing Loss, Noise-Induced
Primary: Percentage of Time Spent at Sound Levels >80 Decibels — 4.4; 5.0; 6.3 percentage of time — p=0.289
N/A N=24 Benefits of the HiResolution Bionic Ear System in Adults With Asymmetric Hearing Loss
Hearing Loss · Ear Diseases · Hearing Disorders
Primary: Change in Consonant Nucleus-Consonant (CNC) Word Recognition Test (Implanted Ear Only) — 2.13; 61.14 percentage of recognized words
N/A N=107 Sensory Integration of Auditory and Visual Cues in Diverse Contexts
Vestibular Disorder · Hearing Loss, Sensorineural
Primary: Root Mean Square Velocity Anterior-posterior [AP] in cm/s (RMSV) — 3.59; 3.30; 3.07 cm/s — p=0.005
N/A N=11 Audiovestibular Function in Infratentorial Superficial Siderosis
Siderosis · Neurological Disorder · Rare Diseases
Primary: Hearing Evaluation - Pure Tone Audiometry — 57.3 decibel hearing level
N/A N=106 Promoting Early Diagnosis of Congenital Hearing Loss With Patient Navigators
Congenital Hearing Loss
Primary: Number of Participants Who do Not Receive Diagnostic Audiological Testing (Aim 1) — 15; 8 Participants
Phase 3 N=115 Efficacy of SENS 401 in Subjects With Severe or Profound Sudden Sensorineural Hearing Loss
Severe Sudden Sensorineural Hearing Loss
Primary: Change in Pure Tone Audiometry PTA (dB) (Average of the Hearing Threshold of the 3 Contiguous Most Affected Hearing Frequencies in dB as Identified at Study Entry) From…
Phase 2 N=72 Micronutrients to Prevent Noise-induced Hearing Loss
Noise-Induced Hearing Loss
Primary: Average Threshold Shift at 4 kHz in Both Ears — 3.94; 3.4; 2.77; 2.03 decibels — p=0.58
N/A N=48 The EarLens System Long Term Safety and Efficacy Definitive Multi-Center Study
Hearing Impairment
Primary: Change in Mean Aided Word Recognition Scores (WRS) When Compared to the Baseline Unaided Condition. — 37.6 percentage of words correctly identified — p=<0.0001
N/A N=10 Cochlear Implantation After Labyrinthectomy or a Translabyrinthine Surgical Approach
Unilateral Acoustic Neuroma · Meniere's Disease
Primary: Change in Consonant-Nucleus-Consonant (CNC) Words Scores Over Time — 23.6; 22; 18.8; 42.7 Percentage of words correct
N/A N=10 Implantation of the Cochlear® Nucleus® System in Adults With Single-Sided Deafness
Single Sided Deafness
Primary: Number of Subjects With Adverse Events — 1 participants
N/A N=20 Cochlear Implantation in Pediatric Cases of Unilateral Hearing Loss
Hearing Loss, Unilateral
Primary: Change Over Time in the Ability to Perceive Single Words as Assessed by Consonant-Nucleus-Consonant (CNC) Word Recognition Testing — 1.4; 14.4; 28.2; 45.0 percentage of…
N/A N=1,098 Communities Helping the Hearing of Infants by Reaching Parents
Congenital Hearing Loss
Primary: Number of Participants Who do Not Receive Diagnostic Audiological Testing (Aim 1) — 378; 336 Participants
N/A N=34 Longitudinal Outcomes of Hearing Aids
Presbycusis
Primary: Hearing Aid Benefit as Measured by the Glasgow Hearing Aid Benefit Profile (GHABP) — 3.68; 3.55; 3.63 score on a scale
N/A N=64 Study of Low Level Laser Therapy and Word Recognition in Hearing Impaired Individuals
Sensorineural Hearing Loss
Primary: Participants Whose Change in Percent Correct Word Recognition Scores From Baseline to One Week After Study Treatment Equalled or Exceeded the Minimum Change in a…
N/A N=68 Clinical Validation of the Lexie Lumen Hearing Aid
Hearing Loss
Primary: Abbreviated Profile of Hearing Aid Benefit (APHAB) — 30.1; 21.4 score on a scale (1-99)
N/A N=57 Esteem Totally Implantable Hearing System
Mild to Severe Sensorineural Hearing Loss
Primary: SRT Change — 10.6 dB
N/A N=43 Cochlear Implantation in Cases of Single-Sided Deafness
Unilateral Moderate to Profound Hearing Loss · Asymmetric Hearing Loss · Single-Sided Deafness (SSD)
Primary: Change in Word Recognition in Quiet Over Time — 4; 8; 0; 0 percentage of words correctly repeated — p=<0.001
N/A N=32 Effects of PSAPs on Speech Processing
Hearing Loss, Age-Related
Primary: Percentage of Correct Responses With and Without PSAPs — 85.2; 84.0 percentage of correct answers — p=0.03
N/A N=45 Interaural Frequency and Loudness Mismatch in SSD CI Users
Outcomes
Primary: Speech Understanding in Noise, Measured With the R-Space Test Environment. The R-Space Test Environment Simulates Speech Understanding in a Noisy Restaurant. — -3.0…
N/A N=118 Smartphone Enabled Hearing Study
Hearing
Primary: International Outcome Inventory for Hearing Aids (IOI-HA) Survey Results — 25.5; 26.6 score on a scale
N/A N=236 Otoacoustic Emission Suppression Study
Neonatal Hearing Loss
Primary: Otoacoustic Suppression Measure — 1.95; 1.33; 2.48; 0.36 dB - Unitless Difference in dB SPL
N/A N=151 Baltimore HEARS: Hearing Health Equity Through Accessible Research & Solutions
Age-related Hearing Impairment 1 · Personal Communication
Primary: Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE-S) — -13.2; .06 score on a scale
N/A N=27 Audiobooks for Hearing Loss App as Auditory Training
Hearing Loss · Hearing Impaired Children · Hearing Impairment
Primary: Audiobooks Efficacy: Change in Slope of Curve for SNR Loss Scores on a Scale/Week for Partial BKB-SIN Hearing Test — 5.978; 5.889; 5.757; 5.600 units on a scale/week…
N/A N=50 Evaluation of the Nucleus Hybrid™ L24 Cochlear Implant System
Sensorineural Hearing Loss
Primary: Consonant Nucleus Consonant (CNC) Monosyllabic Word Score-Treated Ear (CO-PRIMARY) — 65.4 percentage of words correct