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: Number of Subjects With Adverse Events — 1 participants

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

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

Primary: Hearing Improvement — 30.7; 28.7 dB

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

Primary: Percentage of Tinnitus Functional Index (TFI) Responders at Weeks 4 and at Week 8 — 20; 27 Participants — p==0.385

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

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

Primary: The Number of DVD at Week 12 (Defined as the 4-week [28 Days] Interval From Week 9 Through Week 12). — 2.191; 2.415 Definitive Vertigo Day — p=0.623

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

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: 28-Day Average DVD at Week 12 (Month 3) — 2.869; 3.577 DVD — p=0.312

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: Incidence of Device- and Procedure-related Adverse Events at 30 Days — 0 participants

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: Standing Vertigo Intensity — 165.10; 155.10; 136.60 mm*day — p=0.8466

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…

Primary: Vertigo Attacks — 16.4; 19.93; 1.6; 2.5 Vertigo Attacks — p=0.271

Primary: Percentage of Time Spent at Sound Levels >80 Decibels — 4.4; 5.0; 6.3 percentage of time — p=0.289

Primary: Average Threshold Shift at 4 kHz in Both Ears — 3.94; 3.4; 2.77; 2.03 decibels — p=0.58

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 Intelligibility Test in Noise — 0.83; -2.49; -2.74 decibel (dB) Signal-to-Noise Ratio — p=0.0001

Primary: Change in Objective Tinnitus Loudness — -6.1; -9.5; -10.2; -11.0 decibels sensation level (dB SL)

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

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

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