Phase 3 N=255 Sudden Deafness Treatment Trial
Sudden Deafness
Primary: Hearing Improvement — 30.7; 28.7 dB
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Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
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=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=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
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
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=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
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
Phase 3 N=60 Transtympanic Gentamicin vs. Steroids in Refractory Meniere's Disease
Meniere's Disease
Primary: Vertigo Attacks — 16.4; 19.93; 1.6; 2.5 Vertigo Attacks — p=0.271
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
Phase 2 N=12 A Clinical Trial of Anakinra for Steroid-Resistant Autoimmune Inner Ear Disease
Sensorineural Hearing Loss · Autoimmune Inner Ear Disease
Primary: To Assess the Potential Efficacy of Anakinra in Improving Hearing Thresholds in Corticosteroid-resistant Patients With Autoimmune Inner Ear Disease — 7 responders
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=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
Phase 2 N=107 Efficacy of SENS-111 in Patients Suffering From Acute Unilateral Vestibulopathy
Acute Unilateral Vestibulopathy (AUV)
Primary: Standing Vertigo Intensity — 165.10; 155.10; 136.60 mm*day — p=0.8466
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=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
Phase 2 N=53 Antioxidation Medication for Noise-induced Hearing Loss
Hearing Loss
Primary: Temporary Threshold Shift Measurement by Pure Tone Audiometry (A Total of Four Hearing Assessments Were Completed for Each Formulation Period on the 1st Day Pre- and…
Phase 2 N=83 Otoprotection With SPI-1005 for Prevention of Temporary Auditory Threshold Shift
Temporary Auditory Threshold Shift
Primary: Change in Temporary Threshold Shift at 4 kHz--Intent To Treat (ITT) Population — 3.23; 1.32; 3.81; 4.07 dbHL — p=<0.05
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=57 Esteem Totally Implantable Hearing System
Mild to Severe Sensorineural Hearing Loss
Primary: SRT Change — 10.6 dB
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
Phase 3 N=131 Sodium Thiosulfate in Preventing Hearing Loss in Young Patients Receiving Cisplatin for Newly Diagnosed Germ Cell Tumor, Hepatoblastoma, Medulloblastoma, Neuroblastoma, Osteosarcoma, or Other Malignancy
Brain Tumor · Central Nervous System Tumor · Childhood Germ Cell Tumor
Primary: Incidence of Hearing Loss — 14; 31 Patients
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 3 N=10 Intratympanic Steroid for Bell's Palsy
Bell's Palsy · Facial Nerve Paresis
Primary: Facial Nerve Recovery — 7; 81.56 Days
Phase 2 N=28 Evaluation of the Presence of SENS-401 in the Perilymph
Hearing Loss
Primary: Proportion of Participants With SENS-401 Detected in Perilymph — 15; 0 Participants
Phase 2 N=22 Safety, Tolerability and Efficacy for CGF166 in Patients With Unilateral or Bilateral Severe-to-profound Hearing Loss
Unilateral Severe to Profound Hearing Loss OR Bilateral Severe to Profound Hearing Loss
Primary: Number of Participants With Adverse Events — 3; 6; 4; 3 Participants
N/A N=29 Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System
Hearing Loss
Primary: Change in Hearing Performance With the Osia 2 System at 3 Months Post-surgery Compared to Preoperative Unaided Condition Assessed Via Audiometric Thresholds — -27.3 db…
Phase 2 N=28 Phase I/IIa Study Evaluating Safety and Efficacy of an Intratympanic Dose of PIPE-505 in Subjects With Hearing Loss
Sensorineural Hearing Loss
Primary: Safety: Treatment-Emergent Adverse Events (TEAE) — 13; 5 Participants
Phase 2 N=16 Sodium Thiosulfate in Preventing Ototoxicity for Squamous Cell Cancer Patients Undergoing Chemoradiation With Cisplatin
Clinical Stage III Human Papillomavirus (HPV)-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 · Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 · Locally Advanced Head and Neck Squamous Cell Carcinoma
Primary: Number of Participants Who Successfully Completed Planned Treatment — 15 Participants
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…