SBIR-STTR Award

Otitis media or middle ear infections is a prevalent disease associated with early childhood. The primary surgical intervention for persistent and recurring otitis media is insertion of ear tubes (tympanostomy/ myringotomy tubes). There are about 670,000 ear tubes placed annually in the United States. A recognized risk with ear tubes is secondary infection or post-operative otorrhea. The rate of secondary infections is as high as 26% any time ear tubes are in place. Absence of self-protective properties either inherently or in concert with the host’s immune system makes ear tubes prone to infection. Recurrent infections need to be addressed effectively and quickly as it can lead to hearing loss, speech defects and other developmental delays in children. Antimicrobial technologies on ear tubes intended to address the above need have been commercialized in the past. These include Medtronic’s ActiventTM ear tubes with eluting silver technologies and Olympus’ Pacific/ UltraSilTM which are passive technologies. These antimicrobial ear tubes provide limited long-term protection due to rapid depletion of active agents and/ or inactivation under biological milieu. Ear tubes being long-term implants need better protection to prevent recurrent infections. Applicants have developed a unique technology to reduce the risk of long-term ear tube-related infections. The proposed non-depleting active technology will have broad spectrum efficacy without relying on release of active agent(s). The goal of the proposed feasibility studies is to assess safety and antimicrobial performance of the novel ear tubes in appropriate preclinical models. In the first phase of the proposed evaluation, design refinement and development is proposed to identify optimum parameters for the technology which will result in robust ear tube design. In the next stage of evaluation, antimicrobial efficacy (including broad spectrum activity) will be assessed on the lead design candidates in an in vitro model that simulates middle ear environment. Reduction in microbial colonization on novel ear tubes will be reported relative to growth on an uncoated control ear tube and commercial antimicrobial ear tubes. Finally, safety and biocompatibility of the lead design will be assessed in an animal model (chinchillas) to ensure the tympanic membrane and other middle ear structures are not adversely affected by the presence of proposed technology on ear tubes. Appropriate sample size and controls (uncoated ear tubes and commercially available antimicrobial ear tube) will be employed in the proposed studies. The expected outcome of this proof-of-concept phase of the project will be to demonstrate adequate safety in vivo and antimicrobial efficacy of the new technology in vitro. Demonstration of feasibility will set the stage for further commercial development of the technology.

Public Health Relevance Statement:
NARRATIVE Ear tubes are placed in the ear drum to drain infected fluid from the middle ear. Ear tube placements are one of the most common procedures performed in the United States. However, they are susceptible to secondary infections leading to recurrence of symptoms which may lead to hearing loss and speech defects. In addition, the US healthcare system spends billions of dollars each year addressing this issue. The proposed commercialization project intends to study a unique approach to reduce ear tube infections and provide an effective solution for these patients and clinicians.

Project Terms:
Address; Affect; Animal Model; Animals; antimicrobial; Binding; Biological; biomaterial compatibility; Candida albicans; Chemistry; Child; Chinchilla (genus); clinical efficacy; commercialization; conditioning; Contralateral; Copper; Defect; Deposition; design; Development; Developmental Delay Disorders; Devices; Disease; Ear; early childhood; efficacy testing; Ensure; Environment; Evaluation; experimental study; Exposure to; Feasibility Studies; Goals; Growth; Healthcare Systems; hearing impairment; hearing threshold; Histologic; Immune system; Implant; In Vitro; in vitro Model; in vivo; Infection; Influenza; Lead; Liquid substance; Medical Device; Methods; microbial; microbial colonization; middle ear; Modification; Moraxella (Branhamella) catarrhalis; Mucous body substance; Mycoses; new technology; novel; Operative Surgical Procedures; Otitis Media; Otorrhea; Outcome; Particulate; pathogen; Patients; Performance; Phase; phase 1 study; Polymers; Postoperative Period; Pre-Clinical Model; Preparation; prevent; Procedures; product development; Property; Pseudomonas aeruginosa; Recurrence; Reporting; Research Personnel; Risk; Safety; Sample Size; secondary infection; Secondary to; Silicones; Silver; Speech; Streptococcus pneumoniae; Structure; Surface; Symptoms; Techniques; Technology; technology development; Thick; Time; Tube; Tympanic membrane; Tympanostomy; United States;