Referred Ear Pain After Inspire Surgery
Yes, ear pain has been reported as a complication following Inspire hypoglossal nerve stimulation (HNS) surgery, though it is not among the most commonly documented adverse events.
Evidence from Adverse Event Databases
The FDA MAUDE database reviews provide the most comprehensive safety data for Inspire devices. In a 5-year analysis of 132 patient reports containing 134 adverse events, the most commonly reported complications were infection (34.2%), neuropraxia (15.1%), and hematoma/seroma (11.6%) 1. A separate MAUDE database review covering January 2000 to May 2020 with 180 reports similarly identified infection (34.2%), neuropraxia (15.1%), and hematoma/seroma (11.6%) as the predominant adverse events 2.
While ear pain is not explicitly listed among the top complications in these large database reviews, one case series specifically documented "intramuscular sensory lead tract causing pain" as a device-related complication requiring intervention 3. This type of pain could manifest as referred ear pain given the anatomical proximity of the hypoglossal nerve stimulator components to structures that share sensory innervation with the ear.
Pain-Related Complications
Beyond direct ear pain reports:
- Tongue discomfort was noted as a common nonserious complication in pediatric patients 4
- Neuropraxia (nerve injury causing pain/dysfunction) occurred in approximately 15% of reported cases 1, 2
- Device migration and lead-related issues can cause localized pain that may refer to the ear 3, 1
Clinical Context
The European Respiratory Society guidelines note that in the TESLA trial (transcutaneous HNS), "patients reported no skin discomfort or unpleasant sensations at night" with good device acceptance 5. However, this refers specifically to transcutaneous rather than implanted devices.
Overall, serious device-related complications remain rare at approximately 6% after 1- and 5-year follow-up 6, but pain-related symptoms including potential referred ear pain should be considered in the differential diagnosis of post-operative complaints.
Common Pitfalls
When evaluating post-operative pain after Inspire surgery:
- Do not dismiss vague pain complaints as they may indicate lead migration, infection, or nerve irritation requiring imaging
- CT scanning is critical for diagnosis of device malfunction or migration 3
- Consider that pain may be referred from the hypoglossal nerve distribution, surgical site, or device components rather than primary ear pathology