Ear Foundation Santa Barbara Home Page

To purchase the available drug-free form of Patul-END, see the "Products" link.

The Ear Foundation of Santa Barbara is a non-profit organization based in California that was founded on July 2, 1979 because of the mutual concern of Joseph Di Bartolomeo, M.D., and the late Burl Ives, about the prevalence of hearing disorders in the community.

The interest of the Ear Foundation is primarily in public education, medical training, and research related to diseases of the ear. This includes hearing loss, equilibrium disorders and tinnitus. More recently, great strides have been made in healing the Patulous Eustachian Tube.

The Ear Foundation is dedicated to the investigation of diseases affecting hearing or equilibrium and to a better understanding of such disorders through professional and public education.

Our goal is to bring better hearing to all. One out of every 12 individuals in our community suffers from some type of hearing loss. It affects both sexes and all ages…when present at birth it interferes with the development of speech; in children it inhibits proper emotional and social growth; in young adults hearing loss limits participation as vital members of our working community; in the mature or elderly, it can gradually cause isolation from daily involvement in life’s activities – a dreary and lonely prospect.

The Ear Foundation recognizes that good hearing and equilibrium are essential in the pursuit of a richer family life, a broad area of vocations, and independence in work and retirement.

The Clinical Study of the Patulous Eustachian Tube

The clinical study is a double-blind, phase III, F.D.A. study of an Investigational New Drug (IND # 40,202) for severe patulous Eustachian tube. The medication is an Orphan Drug (# 96-988), which is an F.D.A. classification for medication for rare disorders. While semi-patulous Eustachian tube disorder is uncommon, the patulous eustachian tube (severe form) is rare.

Because he suffered from the symptoms of autophony, amphoria and crackling of the ears, Dr. Di Bartolomeo researched the literature to find an answer to this rare disorder. While discovering the cause of these symptoms, he began to research a safe medical treatment. These findings were published in various otologic publications to encourage physicians to think of the patulous eustachian tube condition when a patient has a complaint of a ‘plugged ear,’ are disturbed by their own voice or breath sounds, and the ear examination by the specialist and the tympanogram test are completely normal. This is the time to suspect a PET. Initial clinical study results were published in “A New Medication to Control Patulous Eustachian Tube Disorder,” American Journal of Otolaryngology 18:323-327. Two clinical studies followed and the final “phase III” study has begun.

The Medication

The medication is in the form of nose drops. The method of administration is critical to its effectiveness. The patients' head is tilted 90° toward the effected side so that the drops reach the Eustachian tube opening. The patient sniffs the drops back to the Eustachian tube opening. Some patients can experience a stinging sensation with either the medicine or the placebo, but not all patients will experience this. The ingredients, or composition, for investigational medication is proprietary. The composition of the formula evaluated by the FDA in the previous study has been withdrawn voluntarily, and is not being manufactured. Further research, as suggested by the FDA, has resulted in proposing a new formula, which will be evaluated in the phase III clinical study pending FDA approval.

Forms

Click on the link for printable versions

Frequently Asked Questions

Pre-Trial Daily Record

Patient History Questionnaire

Daily Record

Symptom Improvement Questionnaire

Co-Investigator Equipment and other Requirements

Objective real-time measurement of the Eustachian tube function is required in the study. For more information on this test refer to: Henry DF, Di Bartolomeo JR. “Patulous Eustachian Tube Identification Using Tympanometry.” Journal of American Academy of Audiology. 1993:4, pp. 53-57.

Interested potential co-investigators need submit:

1. A letter of interest
2. Signed Waiver of Disclosure
3. Copy of Medical Liability Insurance
4. Copy of Medical Licensure
5. Copy of CV

Contact Information

For information on how you can be participant in the Patulous Eustachian Tube Study, please contact the Executive Office:

The Ear Foundation
2420 Castillo St, Suite 100
Santa Barbara CA, 93105-4346
Tel: (805) 569-1111
Fax: (805) 563-2277
E-mail: info@earfdn.org

Monetary Contributions and Middle
and Inner Ear Organ Bequests

Contributions may be made to the Ear Foundation in the Memory of a loved one, to support research on the causes and treatment of ear diseases, and to enable us to continue professional education and public service programs in our communities. Property, securities, insurance, charitable remainder trusts and other vehicles may also be donated. You may bequeath your middle ear structures for possible transplant. Information about contributions and donations of ear structures should be directed to:

The Ear Foundation
2420 Castillo Street, Suite 100
Santa Barbara, CA 93105-4346
Tel: (805) 569-1111