Preliminary evaluation of a novel bone-conduction device for single-sided deafness

Area of Science:

• Audiology and Bioengineering
• Medical Devices
• Hearing Science

Background:

• Existing bone-conduction devices for single-sided deafness (SSD) have limitations including suboptimal microphone placement, restricted frequency range, and the need for invasive surgery.
• A new intraoral device aims to overcome these limitations by utilizing an in-ear canal microphone and delivering bone-conduction signals via a removable oral appliance placed on the teeth.

Purpose of the Study:

• To evaluate the safety, efficacy, and user experience of a novel intraoral bone-conduction device for individuals with single-sided deafness (SSD).
• To compare the performance and characteristics of the new device against existing bone-conduction solutions.

Main Methods:

• Mechanical testing compared oral appliance forces to normal mastication forces; extracted teeth assessed surface changes; transducer temperature was monitored.
• Dynamic operating range (gain, bandwidth, output limits) was determined using loudness and vibrotactile thresholds.
• Speech recognition and auditory performance in noise (Hearing in Noise Test) were assessed in normal-hearing and SSD subjects, respectively. User comfort and usability were also evaluated.

Main Results:

• The oral appliance generated forces well below physiological levels and did not damage tooth surfaces or overheat.
• The device provided a wide frequency range (250–12,000 Hz) with adjustable gain, preventing tactile interference.
• SSD subjects showed significant auditory performance improvement with the device; it was comfortable, easy to use, and comparable to traditional hearing aids.

Conclusions:

• The novel intraoral bone-conduction device presents a promising, non-surgical approach for managing single-sided deafness (SSD).
• The device optimizes microphone placement for improved spatial cue reception and offers a broader frequency bandwidth than existing options.
• Laboratory and initial clinical assessments indicate the device is safe, effective, comfortable, and offers substantial auditory benefits for SSD patients.