A Novel Intraoral Bone Conduction Hearing Prosthesis: One-Year Safety and Efficacy Study

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Abstract

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.

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