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Home » Topics » Disease categories and therapies » Ear, nose and throat

Ear, nose and throat
Ear, nose and throat RSS Feed RSS

Robotol surgical robot

First cochlear implant placed using robotic guidance in a hybrid operating room

Jan. 12, 2022
By Bernard Banga
PARIS – The team from the ENT surgery department at Clermont-Ferrand University Hospital recently placed a cochlear implant into a patient with profound deafness using the Collin Medical SAS otologic robot in a hybrid operating room known as Imabloc.
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Photo of doctor inserting hearing aid in patient's ear

FDA’s hearing aid draft rule pushes agency back into debate over class II device preemption

Oct. 19, 2021
By Mark McCarty
The FDA published a draft rule on Oct. 19 for over-the-counter hearing aids, four years after the Food and Drug Administration Reauthorization Act (FDARA) had directed the agency to do so by 2020. One of the potentially more problematic aspects of the draft is that the rule would be preemptive of state law on several points, including consumer protections, a consideration that could serve as a flashpoint in future litigation.
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Acquisition target

Innerscope acquires Ihear, expands direct-to-consumer hearing aid platform

Oct. 5, 2021
By Annette Boyle
Innerscope Hearing Technologies Inc. acquired the assets and operations of Ihear Medical Inc. for an undisclosed amount. The deal significantly boosts Innerscope’s position in the emerging market of direct-to-consumer and over-the-counter hearing products, an important development in the run-up to the FDA’s expected release next month of new regulations for hearing aids that can be sold in stores without a prescription.
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Rockefeller University presents new LATS1 inhibitors

Sep. 1, 2021
Acquisition target

Medtronic’s $1.1B buy of Intersect would solidify its footprint in ENT space

Aug. 6, 2021
By Mark McCarty
Medtronic plc reported it will acquire Intersect ENT, a deal that represents a major expansion of Medtronic’s footprint in the ear/nose/throat (ENT) space. Intersect’s products for chronic rhinosinusitis will give Medtronic access to a medical market said to be among the top 10 most expensive conditions for employers, with a potential patient population of 35 million in the U.S. alone.
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Otonomy announces phase I/II study expansion for OTO-413 in speech-in-noise hearing difficulty

June 16, 2021
Ear illustration

Proqr procures strong phase I/II data and an FDA chat for next steps

March 24, 2021
By Lee Landenberger
RNA therapy developer Proqr Therapeutics NV’s phase I/II study of adults with Usher syndrome and non-syndromic retinitis pigmentosa met all its key objectives, prompting the company to plan two parallel pivotal phase II/III studies that could start by year-end. The company wasted no time as it has already discussed next steps with the FDA to support the therapy’s registration “as soon as possible,” Aniz Girach, Proqr’s chief medical officer, told investors during a March 24 investor call.
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Ear and sound waves illustration

Frequency hears bad news from a phase IIa study of its lead candidate

March 23, 2021
By Lee Landenberger
A phase IIa study of Frequency Therapeutics Inc.’s lead candidate in treating hearing loss showed it fared no better than placebo, but the company said its faith in the candidate is bolstered by the belief the study was hampered by trial design issues and by data from another study.
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Frequency Therapeutics reports phase IIa data on FX-322 in sensorineural hearing loss

March 23, 2021

Gene therapy for TMPRSS3 hearing loss shows promise with late intervention in mouse model

March 8, 2021
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