Clinical Trial Search

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…

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

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

Primary: Speech Perception in Quiet (Monosyllables) in Patients Implanted With Vibrant Soundbridge — 94.12 percentage of words correct

Primary: Change in Consonant Nucleus-Consonant (CNC) Word Recognition Test (Implanted Ear Only) — 2.13; 61.14 percentage of recognized words

Primary: Root Mean Square Velocity Anterior-posterior [AP] in cm/s (RMSV) — 3.59; 3.30; 3.07 cm/s — p=0.005

Primary: HEAR-QL 26 Questionnaire — 69.61; 74.05; 71.04; 80.21 score on a scale

Primary: Change in Consonant-Nucleus-Consonant (CNC) Words Scores Over Time — 23.6; 22; 18.8; 42.7 Percentage of words correct

Primary: Change From Baseline in Adaptive Speech in Noise Test Score for Osia 2 System at 3 Months Post-surgery — 6.1 Score on a scale

Primary: Number of Subjects With Adverse Events — 1 participants

Primary: Hearing Evaluation - Pure Tone Audiometry — 57.3 decibel hearing level

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…

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

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…

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

Primary: Change in CNC Word Perception — 27.6; 34; 55.9; 68 percentage of words correct

Primary: Change in Word Recognition in Quiet Over Time — 4; 8; 0; 0 percentage of words correctly repeated — p=<0.001

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

Primary: To Assess the Improvement of Hearing With the Sentio1 (PTA4) — 32.5 dB

Primary: Hamilton Rating Score for Depression (HRSD) — 12.04; 13.86 score on a scale

Primary: Number of Participants Who do Not Receive Diagnostic Audiological Testing (Aim 1) — 15; 8 Participants

Primary: Consonant Nucleus Consonant (CNC) Monosyllabic Word Score-Treated Ear (CO-PRIMARY) — 65.4 percentage of words correct

Primary: Abbreviated Profile of Hearing Aid Benefit (APHAB) — 6.3; 7.0; 5.6; 3.5 units on a scale

Primary: Experimental Middle Ear Test: Ambient Wideband Absorbance — 0.39; 0.38; 0.32 Ratio

Primary: Vestibular "Endolymphatic Hydrops (EH)" — 0; 4; 2 participants

Primary: Lateralization Hearing Ability — 71; 54 percent correct responses — p=<.05

Primary: Number of Participants With Treatment-emergent Adverse Event(s) (TEAEs) — 2; 3; 5; 6 Participants

Primary: Hearing Aid Use Measured Using In-situ Glasgow Hearing Aid Benefit Profile (EMA-GHABP-Use) — 4.4; 4.1; 3.8; 4.5 score on a scale

Primary: Cochlear Implant: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test. — 8.45; 10.4; 21.2; 22.2 ratio

Primary: Safety Outcome Measure: Proportion of Adverse Events (AEs) Related to Sophono Implant — 0.038 Proportion of Adverse Events