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tympanostomy tube · 1 trial · 2 indications
Occurrence of pre-defined Safety Events of acoustic trauma, deployment of the TT into the middle ear, damage to middle ear structures, unintended tympanic membrane perforation requiring treatment, abrasion to the external acoustic meatus requiring significant treatment, and major bleeding requiring significant treatment.
Device Success is defined as the successful delivery of the tympanostomy tube across the tympanic membrane using the tympanostomy tube delivery system (TTDS).Device Success is evaluated on a per device basis.
| Arm | Type | Description |
|---|---|---|
| tympanostomy tube | EXPERIMENTAL | performance and safety of tympanostomy tube delivery system |
| Name | Type | Description |
|---|---|---|
| tympanostomy tube | DEVICE | tympanostomy tube delivery system |
Inclusion Criteria: * Diagnosed with either chronic otitis media with effusion or acute otitis media and scheduled to undergo tympanostomy tube insertion Exclusion Criteria: * Reaction to anesthesia * Markedly atrophic, bimeric, severely retracted, atelectatic or perforated tympanic membrane * Ot...
A tympanostomy tube is used for otitis media with effusion, a condition where fluid builds up in the middle ear. It is a small tube surgically placed in the eardrum to ventilate the middle ear and prevent fluid accumulation. The device is being developed by Integra LifeSciences Holdings Corporation.
Integra LifeSciences Holdings Corporation (NASDAQ: IART) is developing the tympanostomy tube. The company is conducting clinical research on this device for the treatment of otitis media with effusion, a middle ear condition characterized by fluid buildup.
The tympanostomy tube is in Phase 2 clinical development. It is an investigational device and has not been approved by the FDA. One Phase 2 trial has been completed, evaluating the device's delivery system in patients with otitis media with effusion.
The tympanostomy tube has been studied in one completed Phase 2 clinical trial, NCT01202578, titled 'Evaluation of the Tympanostomy Tube Delivery System.' The trial enrolled 53 participants in the United States, including children as young as 6 months, with conditions of otitis media with effusion and acute otitis media.
The tympanostomy tube is not FDA approved. It is an investigational device currently in Phase 2 clinical development. A completed Phase 2 trial (NCT01202578) has evaluated its delivery system, but the device has not yet received regulatory approval.