The magnet-drive hearing device (MHD) is a small completely-in-the-canal hearing aid prototype that drives the tympanic membrane (TM) through a magnetic interface. A cadaveric temporal bone was prepared. The MHD was coupled to a nickel-epoxy pellet glued to the umbo. Frequency sweeps between 0.3 and 10 kHz were performed, and the MHD was driven with various levels of current. Displacements of the posterior crus of the stapes were measured using a laser Doppler vibrometer and compared with sound-induced displacements. The MHD had a linear frequency response and low total harmonic distortion. The pellet placement altered the stapes movements; however, the changes were statistically insignificant. Inputs of 100 and 300 mV produced displacements equivalent to those of the natural sound at 70- and 80-dB sound pressure level, respectively. The coupling of this novel device using a magnetic interface to the umbo had a frequency output wider than air conduction devices, and its actuator was effective in driving the TM.

The direct hearing device (DHD) is a new auditory prosthesis that combines conventional hearing aid and middle ear implant technologies into a single device. The DHD is located deep in the ear canal and recreates sounds with mechanical movements of the tympanic membrane. A critical component of the DHD is the microactuator, which must be capable of moving the tympanic membrane at frequencies and magnitudes appropriate for normal hearing, with little distortion. The DHD actuator reported here utilized a voice coil actuator design and was 3.7 mm in diameter. The device has a smoothly varying frequency response and produces a precisely controllable force. The total harmonic distortion between 425 Hz and 10 kHz is below 0.5 % and acoustic noise generation is minimal. The device was tested as a tympanic membrane driver on cadaveric temporal bones where the device was coupled to the umbo of the tympanic membrane. The DHD successfully recreated ossicular chain movements across the frequencies of human hearing while demonstrating controllable magnitude. Moreover, the micro-actuator was validated in a short-term human clinical performance study where sound matching and complex audio waveforms were evaluated by a healthy subject.

Objectives/hypothesis

To develop a novel completely-in-the-canal device capable of directly driving the tympanic membrane (TM) and ossicular chain from the ear canal.

Study design

Development and feasibility study.

Methods

A voice coil actuator design was developed to drive the TM. Bench testing of the device using laser Doppler vibrometry (LDV) and sound recording was performed. Temporal bone studies using LDV were performed using different designs of the contact tip-TM interface to find the most efficient method of sound transmission. Two short-term clinical performance studies were performed using the latest 3-mm-wide device. Comparison was made to natural sound and to the Vibrant SoundBridge floating mass transducer simulator.

Results

On bench testing, the device was found to have a low (<0.5%) total harmonic distortion in all frequencies above 400 Hz. Temporal bone studies revealed the device was capable of producing vibrations equivalent to 104 to 120 dB sound across most frequencies. The most efficient method of stimulation was when the device was coupled to the malleus. Short-term clinical performance studies indicated that pure tones and complex sound can be presented with the device. The sound quality of the experimental device was rated as better than the SoundBridge simulator device.

Conclusions

The direct-drive hearing device is capable of producing a wide range of sound frequencies and amplitudes. The device can transmit complex sound with low power requirements. Further work on the development of the device is needed for long-term and wider clinical use.

Level of evidence

NA Laryngoscope, 127:932-938, 2017.