Soundbites for ages 9 and up is available for direct distribution to your patients now. Soundbites Clinical Care, a low dose, twist-off softgel capsule format for infants and children to age 9, is expected to be available in late 2020. Soundbites Clinical Care is intended for infants and children under doctors’ care for hearing loss indications caused by upregulated inner ear free radicals – GJB2/Connexin 26 genetic mutation, ototoxic side effect of aminoglycoside antibiotics and other ototoxic pharmaceuticals, and the hearing loss side effect of cCMV (congenital cytomegalovirus). Please contact email@example.com for more information about providing Soundbites to your patients.
For Principal Investigators
Identical Soundbites active and placebo softgel capsule have been approved as an Investigational New Drug (FDA IND) and an Investigational Medicinal Product (EU IMP) for use in RCT studies. IND- and IMP-compliant study medication can be made available to PIs wishing to conduct RCTs on the Soundbites intervention for SNHL indications and related neurological disorders.
Additionally, Soundbites PBC, in alliance with the Keep Hearing 501c3 nonprofit, has developed a Phase IV post-marketing RW studies protocol using a mobile-enabled, scale-free, single-arm N-of-1 framework deployed on the HIPAA- and FISMA-compliant FDA MyStudies app platform tor study effectiveness of Soundbites as an intervention for NIHL, ARHL, tinnitus and hyperacusis. Please contact firstname.lastname@example.org to learn more.