Objective: To assess the safety and efficacy of an intraoral bone conduction (IOBC) hearing prosthesis after 12 months of use.
Study design: Prospective cohort study.
Setting: Multisite study including private practice, hospital-based practice, tertiary care, and academic medical centers.
Patients: Patients aged 18 years or older with single-sided deafness (SSD).
Main outcome measure(s): At the end of 6 months and 12 months, patients were asked to complete the Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire and SSD questionnaire in addition to audiometric testing.
Results: Eighty-one patients completed the study. Hearing thresholds remained the same throughout the study. APHAB results showed a significant benefit (p < 0.001) in categories of ease of communication, reverberation, background noise, and global score. The SSD questionnaire showed a high satisfaction among participants, with 93.8% of patients likely to recommend the IOBC. Dissatisfaction was highest with regard to patient's ability to eat with device, with only 55.6% satisfied. No serious adverse events were reported during the study.
Conclusion: The IOBC is a safe and effective alternative to percutaneous osseointegrated hearing implants for patients with SSD. Patient satisfaction and improved hearing benefit are observed after 1 year of using the device. The IOBC significantly benefitted patients in APHAB categories of ease of communication, reverberation, background noise, and the overall global hearing score. The in-the-mouth transducer is the least-liked feature for some patients, particularly with regard to eating; however, the majority of patients are willing to deal with the size of the device for the hearing benefit gained.