Decibel Therapeutics Inc. has received clearance from the FDA for its IND application to initiate a phase I/II trial of DB-OTO in pediatric patients, potentially in infants younger than 2 years of age.

Akouos Inc. has received IND clearance from the FDA to initiate a first-in-human phase I/II pediatric trial of AK-OTOF, a gene therapy intended for the treatment of patients with otoferlin gene (OTOF)-mediated hearing loss.

The EMA's Committee for Orphan Medicinal Products (COMP) has adopted a positive opinion on Sensorion SA's application seeking orphan drug designation for OTOF-GT, a gene therapy intended for the treatment of otoferlin gene-mediated hearing loss.

The U.S. FDA’s rule for over-the-counter (OTC) hearing aids was several years late coming out, but the rule has nonetheless proven controversial from the outset. Two members of the U.S. Senate have blasted device makers for what they allege is interference with the rulemaking process via “astroturf” campaigns to prod hearing aid users to influence the agency’s final rule.

Aerin Medical Inc.’s funding nosed up to $190.5 million with its latest venture capital round, which brought in $60 million in fresh cash. The provider of noninvasive solutions for chronic nasal conditions plans to use the funds to ramp up commercialization and expand market access to its Vivaer and Rhinaer products. New investor Ally Bridge Group led the round with support from returning major investors KCK Medtech, Questa Capital and Orbimed.

Lyra Therapeutics Inc.’s $100.5 million private placement has investors moving to the tune of the ear, nose and throat specialty therapeutics company. Lyra’s stock (NASDAQ:LYRA) jumped from early April trading in the $4.20 range to $6.02 with the announcement April 8 of the pending placement. The stock shot up again on April 13 when the placement finalized and surged in after-hours trading, ultimately spiking over $7 shortly after the opening bell April 14.