Soundbites Clinical Care will be available in 2020
Soundbites for ages 9 and up is available for direct distribution to your patients.
A low dose, twist-off softgel capsule format of Soundbites has been developed for infants and children to age 9. In 2020 it will be available to physicians treating patients with clinical hearing loss indications caused by upregulated inner ear free radicals, including hearing loss from the GJB2/Connexin 26 genetic mutation and other genetic mutations causing upregulated ROS; the hearing loss side effect of aminoglycoside antibiotics and other ototoxic pharmaceuticals, and the hearing loss side effect of cCMV (congenital cytomegalovirus).
To learn more, please contact firstname.lastname@example.org
Soundbites softgel capsules are available for direct distribution to your patients. To learn more, please contact email@example.com
The Soundbites micronutrient intervention has been previously approved as an Investigational New Drug (FDA IND) and an Investigational Medicinal Product (EU IMP) for use as an RCT studies intervention for treating free radical induced hearing loss from noise, and for preserving residual hearing in cochlear implant recipients.
NIHL is the most common and fastest growing indication, but it is medically unethical to expose humans in a clinical trial to levels of noise that are known to cause hearing damage. Consequently, we believe citizen science – evidence-based real world research – is a more appropriate research direction for studying NIHL, and also AARHL, tinnitus and hyperacusis in a variety of cohorts.
Soundbites is marketed under FDA DSHEA regulations as a nutritional supplement. Soundbites PBC offers Principal Investigators a Phase IV post-marketing research protocol using a mobile-enabled, scale-free, single-arm N-of-1 study protocol framework deployed in two phases on the HIPAA- and FISMA-compliant FDA MyStudies app platform. GRAS actives allow online adverse events monitoring and reporting. Please contact firstname.lastname@example.org to learn more.