SBIR-STTR Award

Accurate and early detection of small intracanalicular acoustic tumors is difficult with standard Acoustic Brainstem Response (ABR). As a result, expensive enhanced MRI is used to screen patients suspected of having a tumor. Most patients sent for imaging are negative. Development of a compact cost-efficient screening device based on the Stacked Derived-band ABR Amplitude measure is proposed. The aim of this measure is to insure imaging of patients with tumors and substantially reduce imaging of non-tumor patients. Phase I research will demonstrate that clinically acceptable sensitivity and specificity can be achieved and that digital noise masking can be used in this method. In Phase II, we plan to further improve the sensitivity and specificity by optimizing the parameters of the stacked derived- band ABR method. We will test the optimized method on a large clinical population, and validate the method's clinical utility and ease of use in a multi-center study. We will also develop the PC-based prototype (hardware and software) of the screening device. PROPOSED COMMERCIAL APPLICATION The acoustic tumor screening device will be marketed to Otolaryngology and Audiology as a complete diagnostic system as an option on acoustic and multi-modality EP systems. Otolaryngologists and audiologists have the requisite expertise and facilities to administer and evaluate ABR test results, so that this system would require little additional training and no facility development. The screening device will provide significant benefits in terms of improved patient care and reduced diagnostic costs.

Thesaurus Terms:
biomedical equipment development, diagnosis design /evaluation, ear disorder diagnosis, ear neoplasm, evoked potential, neoplasm /cancer diagnosis clinical biomedical equipment, electrophysiology, sound clinical research, human subject

Accurate and early detection of small acoustic tumors is difficult with standard Auditory Brainstem Response (ABR) measures. As a result, expensive MRt is now used to screen patients suspected of having a tumor. However, most of those screened do not have tumors. Our long-term goal is the development of a compact cost-efficient screening device based on the Stacked ABR, a newly-developed ABR method for detecting small acoustic tumors. This device will insure imaging of patients with tumors while substantiafly reducing imaging of non-tumor patients. In Phase I, we (1) demonstrated that the Stacked ABR method detected small tumors with excellent sensitivity and good specificity in a large clinical population, and (2) developed basic hardware and software components for the commercial device. In Phase II, we will (1) optimize the Stacked ABR method to increase its clinical utility, (2) incorporate the method in a user-friendly prototype, and (3) validate the optimized method and evaluate the prototype in a multi-center Study. Thus, in Phase II, a commercially-viable prototype using optimized Stacked ABR algorithms will be developed, thoroughly tested, and independently validated. This work is crucial to our Phase III goal of developing a user-friendly cost-efficient commercially-available clinical system for the Stacked ABR.

Thesaurus Terms:
iomedical equipment development, diagnosis design /evaluation, ear disorder diagnosis, ear neoplasm, evoked potential, neoplasm /cancer diagnosis clinical biomedical equipment, computer human interaction, electrophysiology, sound clinical research, human subject