Envoy Medical Receives FDA Approval to Expand Acclaim Clinical Trial
Envoy Medical has received FDA approval to expand its pivotal clinical trial for the fully implanted Acclaim cochlear implant, accelerating its path to commercialization.
Tag: clinical trials
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Envoy Medical Selects Study Sites for Trial of Fully Implanted Cochlear Implant
Envoy Medical has chosen seven investigational sites for its pivotal clinical trial of the fully implanted Acclaim cochlear implant.
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Audion Therapeutics Publishes Trial Details on Drug Treatment for Sensorineural Hearing Loss
The Phase I part of the study confirmed the safety and tolerability of a dose of 250 microgram of Gamma Secretase Inhibitor LY3056480.
Nuheara to Commence Medical Device Trials for Obtaining FDA and CE Compliance
Nuheara has engaged National Acoustics Laboratories (NAL) under the terms of a Clinical Trial Agreement (CTA) to assist with conducting clinical trials for obtaining FDA and CE compliance for its hearing devices.
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Frequency Therapeutics Reports Disappointing Trial Results for Hearing Restoration Drug
Frequency Therapeutics announced topline results from its recent study, showing that four weekly injections of its FX-322 treatment therapy in subjects with mild to moderately severe sensorineural hearing loss (SNHL) did not demonstrate improvements in hearing measures versus placebo. FX-322, the company’s lead product candidate, made news last month when a study published in ‘Otology & Neurotology’ indicated the “first known linkage of pharmacokinetics and pharmacodynamics for a potential hearing restoration therapy.”
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Frequency Therapeutics Publishes FX-322 Phase 1/2 Results
The data show hearing improvements in adults with acquired sensorineural hearing loss (SNHL) and the “first known linkage of pharmacokinetics and pharmacodynamics for a potential hearing restoration therapy,” according to Frequency.
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Auris Medical Completes Enrollment in Phase 2 Study for Vertigo Drug
The Company expects to release interim results from TRAVERS and commence Part B of the trial in the coming weeks.
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Otonomy Announces Positive Top-Line Results from Tinnitus Drug Trial
The trial reportedly achieved its objectives by demonstrating a positive clinical signal for OTO-313 based on a TFI responder analysis, with a favorable safety profile, according to the company.
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Frequency Therapeutics Announces Clinical Data from Auditory Drug
FX-322 is Frequency’s lead product candidate, designed to regenerate auditory sensory hair cells in the cochlea and improve hearing in patients with sensorineural hearing loss (SNHL).
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Sensorion Announces Updated Timelines for Phase 2 Study of Hearing Loss Drug
Sensorion (FR0012596468 – ALSEN) a clinical-stage biotech company which specializes in the...
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Akouos Announces Gene Therapy to Treat Genetic Hearing Loss
AK-OTOF is intended to treat individuals with sensorineural hearing loss due to mutations in the OTOF gene, who typically have severe hearing loss in both ears from birth, by promoting the expression of normal, functional otoferlin protein in affected cells of the cochlea.
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Sensorion Receives IND Clearance from FDA on Hearing Loss Drug
SENS-401 is under development in the treatment of Sudden Sensorineural Hearing Loss (or SSNHL).
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Sensorion Receives European Medicines Agency Approval for PIP on Hearing Loss Treatment
SENS-401 is under development in the treatment of Sudden Sensorineural Hearing Loss (or SSNHL).
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Sensorion Receives European Medicines Agency Approval for PIP on Hearing Loss Treatment
SENS-401 is under development in the treatment of Sudden Sensorineural Hearing Loss (or SSNHL).
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Otonomy Initiates Clinical Trial for Tinnitus Drug
The randomized, double-blind, placebo-controlled Phase 1/2 study will include an initial safety cohort followed by an exploratory efficacy study that will enroll approximately 50 patients with subjective tinnitus.
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Audion Therapeutics and Regain Consortium Report Positive Phase I Results from Drug to Treat SNHL
LY3056480 mediated Notch inhibition is aimed at regeneration of inner ear sensory hair cells that are lost with advancing age.
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Otonomy Presents Data on OTO-413 Therapy for Hearing Loss
These preclinical data, demonstrating the potential of intratympanic BDNF to repair cochlear synaptopathy—an underlying cause of hearing loss including speech-in-noise hearing difficulty—are being presented as part of the Society for Neuroscience (SfN) Annual Meeting in San Diego, November 3-7, 2018.
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NF2 Trial: An Interview with Rick Friedman, MD, PhD
Hearing Review interviewed Rick Friedman, MD, PhD, about NF2 and an NF2 clinical that is underway in Los Angeles and at 12 other sites in the US. The trial uses the chemotherapy drug Avastin (bevacizumab) as a potential therapy for shrinking NF2 tumors, or stemming their growth.
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