30 closest matches · ranked by relevance
Single Sided Deafness
Primary: Number of Subjects With Adverse Events — 1 participants
Sudden Deafness
Primary: Hearing Improvement — 30.7; 28.7 dB
Siderosis · Neurological Disorder · Rare Diseases
Primary: Hearing Evaluation - Pure Tone Audiometry — 57.3 decibel hearing level
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
Profound Bilateral Deafness Due to · Bilateral Cochlear Aplasia · Bilateral Cochlear Nerve Deficiency
Primary: Primary Endpoint — 6 Participants
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…
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…
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
Hearing Loss, High-Frequency
Primary: Change in CNC Word Perception — 27.6; 34; 55.9; 68 percentage of words correct
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
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
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…
Implants, Cochlear · Child · Hearing Loss, Bilateral
Primary: The Infant-Toddler Meaningful Auditory Integration Scale (IT-MAIS) — 0; 53; 64; 75 percentage out of 40
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
Hearing Loss
Primary: Change in Hearing Aid Benefit as Measured by Abbreviated Profile of Hearing Aid Benefit (APHAB) — -19.74; -14.41 score on a scale — p=0.003
Hearing Loss
Primary: Comparison of Pre-implant Consonant-Nucleus-Consonant (CNC) Scores to Post-implant CNC Scores in Bilateral Users. — 4.0; 69.0 percent of words correct
Developmental Cochlear Nerve Deficiency · Acquired Cochlear Nerve Deficiency · Cochlear Aplasia
Primary: Number of ABI Complications — 2 Events
Unilateral Hearing Loss
Primary: Incidence of Device- and Procedure-related Adverse Events at 30 Days — 0 participants
Sensorineural Hearing Loss
Primary: Consonant Nucleus Consonant (CNC) Monosyllabic Word Score-Treated Ear (CO-PRIMARY) — 65.4 percentage of words correct
Hearing Loss, Sensorineural
Primary: Change in Percent Correct on Word Recognition in Quiet in Implanted Ear — 25.6 Change in percentage points
Deafness; Sensoneural Single Sided · Conductive Hearing Loss · Mixed Hearing Loss
Primary: Hearing Performance: Threshold Audiometry, Pure Tone Average of 4 Frequencies, PTA4, Unaided Versus OSIA System at 3 Months — -25.8 dB (Decibel) — p=<0.0001
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
Congenital Hearing Loss
Primary: Number of Participants Who do Not Receive Diagnostic Audiological Testing (Aim 1) — 15; 8 Participants
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
Meniere's Disease
Primary: Vertigo Attacks — 16.4; 19.93; 1.6; 2.5 Vertigo Attacks — p=0.271
Unilateral Hearing Loss · Unilateral Deafness
Primary: Number of 5 Key Words Within 6 Sentence Lists Repeated Correctly in the Presence of Multitalker Noise — 5.44; 3.5; 4.75; -1.75 words
Hearing Loss, Sensorineural · Hearing Loss, Cochlear · Deafness
Primary: Change in Hearing In Noise Test Score in Quiet (HINT-Q) From Baseline to 6 Months in English-speaking Participants. — 51.5 percent change words correctly repeated
Hearing Loss, Sensorineural · Hearing Loss, Bilateral
Primary: Pre-school Language Test — 82.4 units on a scale
Mild to Severe Sensorineural Hearing Loss
Primary: SRT Change — 10.6 dB
Hearing Loss
Primary: Proportion of Participants With SENS-401 Detected in Perilymph — 15; 0 Participants