Dataset Information

A Precision Driver Device for Intraoperative Stimulation of a Bone Conduction Implant.

ABSTRACT: Semi-implantable bone conduction implants (BCI) and active middle ear implants (AMEI) for patients with sensorineural, conductive or mixed hearing loss commonly use an amplitude modulation technology to transmit power and sound signals from an external audio processor to the implant. In patients, the distance dependence of the signal amplitude is of minor importance as the skin thickness is constant and only varies between 3-7?mm. In this range, critical coupling transmission technique sufficiently reduces the variability in amplitude, but fails to provide well-defined amplitudes in many research and clinical applications such as intraoperative integrity tests where the distance range is exceeded by using sterile covers. Here we used the BCI Bonebridge (BB, Med-El, Austria) as an example to develop and demonstrate a system that synthesizes the transmission signal, determines the distance between the transmitter and the receiver implant coil and compensates transmission losses. When compared to an external audio processor (AP304) on an artificial mastoid, our system mainly decreased amplitude variability from over 11?dB to less than 3?dB for audio frequencies (0.1-10?kHz) at distances up to 15?mm, making it adequate for intraoperative and audiometric tests.

SUBMITTER: Ghoncheh M

PROVIDER: S-EPMC7000405 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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A Precision Driver Device for Intraoperative Stimulation of a Bone Conduction Implant.

Ghoncheh Mohammad M Lenarz Thomas T Maier Hannes H

Scientific reports 20200204 1

Semi-implantable bone conduction implants (BCI) and active middle ear implants (AMEI) for patients with sensorineural, conductive or mixed hearing loss commonly use an amplitude modulation technology to transmit power and sound signals from an external audio processor to the implant. In patients, the distance dependence of the signal amplitude is of minor importance as the skin thickness is constant and only varies between 3-7 mm. In this range, critical coupling transmission technique sufficien ...[more]

PMID: 32019957

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Project description:ObjectivesTo compare contralateral to ipsilateral stimulation with percutaneous and transcutaneous bone conduction implants.BackgroundBone conduction implants (BCIs) effectively treat conductive and mixed hearing losses. In some cases, such as in single-sided deafness, the BCI is implanted contralateral to the remaining healthy ear in an attempt to restore some of the benefits provided by binaural hearing. While the benefit of contralateral stimulation has been shown in at least some patients, it is not clear what cues or mechanisms contribute to this function. Previous studies have investigated the motion of the ossicular chain, skull, and round window in response to bone vibration. Here, we extend those reports by reporting simultaneous measurements of cochlear promontory velocity and intracochlear pressures during bone conduction stimulation with two common BCI attachments, and directly compare ipsilateral to contralateral stimulation.MethodsFresh-frozen whole human heads were prepared bilaterally with mastoidectomies. Intracochlear pressure (PIC) in the scala vestibuli (PSV) and tympani (PST) was measured with fiber optic pressure probes concurrently with cochlear promontory velocity (VProm) via laser Doppler vibrometry during stimulation provided with a closed-field loudspeaker or a BCI. Stimuli were pure tones between 120 and 10,240 Hz, and response magnitudes and phases for PIC and VProm were measured for air and bone conducted sound presentation.ResultsContralateral stimulation produced lower response magnitudes and longer delays than ipsilateral in all measures, particularly for high-frequency stimulation. Contralateral response magnitudes were lower than ipsilateral response magnitudes by up to 10 to 15 dB above ~2 kHz for a skin-penetrating abutment, which increased to 25 to 30 dB and extended to lower frequencies when applied with a transcutaneous (skin drive) attachment.ConclusionsTranscranial attenuation and delay suggest that ipsilateral stimulation will be dominant for frequencies over ~1 kHz, and that complex phase interactions will occur during bilateral or bimodal stimulation. These effects indicate a mechanism by which bilateral users could gain some bilateral advantage.

Project description:To compare implant stability, survival, and soft tissue reactions for a novel (test) and previous generation (control) percutaneous auditory osseointegrated implant for bone conduction hearing at long-term follow-up of 5 years.Single follow-up visit of a previously completed multicenter, randomized, controlled trial.Fifty-seven of the 77 participants of a completed randomized controlled trial on a new auditory osseointegrated implant underwent a single follow-up visit 5 years after implantation, which comprised implant stability measurements and collection of Holgers scores. Additionally, implant survival was recorded for all 77 patients from the original trial.The test implant showed significantly higher implant stability quotient (ISQ) values compared with the control implant throughout the 5-year follow-up. Mean area under the curve of ISQ high from baseline to 5 years was 71.6 (standard deviation [SD] ±2.0) and 66.7 (SD ±3.4) for the test and control implant, respectively (p?<?0.0001). For both implants, the mean ISQ value recorded at 5 years was higher compared with implantation (test group +2.03 [SD ±2.55, within group p?<?0.0001] and control group +2.25 [SD ±4.95, within group p?=?0.12]). No difference was noticed in increase from baseline between groups (p?=?0.64). Furthermore, evaluation of soft tissue reactions continued to show superiority of the test implant. At the 5-year follow-up visit, one patient (2.5%) presented with a Holgers grade 2 in the test group, compared with four patients (23.5%) in the control group (p?=?0.048); no patient presented with more severe soft tissue reactions. Excluding explantations, the survival rate was 95.8% for the test group and 95.0% for the control group. The corresponding rates including explantations were 93.9 and 90.0%.The test implant showed superiority in terms of higher mean ISQ values and less adverse soft tissue reactions, both at the single 5-year follow-up visit and during the complete follow-up. In addition, both implants showed an equally high implant survival.

Dataset Information

A Precision Driver Device for Intraoperative Stimulation of a Bone Conduction Implant.

Publications

A Precision Driver Device for Intraoperative Stimulation of a Bone Conduction Implant.

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