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The bone conduction implant: Clinical results of the first six patients.

Reinfeldt S, Håkansson B, Taghavi H, Fredén Jansson KJ, Eeg-Olofsson M - Int J Audiol (2015)

Bottom Line: The surgical procedure was found uneventful with no adverse events.All BCI results were better than, or similar to the reference device results, and the APHAB and GBI questionnaires scores showed statistically significant improvements versus the unaided situation, supporting the second and third hypotheses.The BCI provides significant hearing rehabilitation for patients with mild-to-moderate conductive or mixed hearing impairments, and can be easily and safely implanted under intact skin.

View Article: PubMed Central - PubMed

Affiliation: * Department of Signals and Systems, Chalmers University of Technology , Gothenburg , Sweden.

ABSTRACT

Objective: To investigate audiological and quality of life outcomes for a new active transcutaneous device, called the bone conduction implant (BCI), where the transducer is implanted under intact skin.

Design: A clinical study with sound field audiometry and questionnaires at six-month follow-up was conducted with a bone-anchored hearing aid on a softband as reference device.

Study sample: Six patients (age 18-67 years) with mild-to-moderate conductive or mixed hearing loss.

Results: The surgical procedure was found uneventful with no adverse events. The first hypothesis that BCI had a statistically significant improvement over the unaided condition was proven by a pure-tone-average improvement of 31.0 dB, a speech recognition threshold improvement in quiet (27.0 dB), and a speech recognition score improvement in noise (51.2 %). At speech levels, the signal-to-noise ratio threshold for BCI was - 5.5 dB. All BCI results were better than, or similar to the reference device results, and the APHAB and GBI questionnaires scores showed statistically significant improvements versus the unaided situation, supporting the second and third hypotheses.

Conclusions: The BCI provides significant hearing rehabilitation for patients with mild-to-moderate conductive or mixed hearing impairments, and can be easily and safely implanted under intact skin.

No MeSH data available.


Related in: MedlinePlus

Tone threshold improvements for BCI and reference device, including mean improvement and standard deviation. BCI PTA4 = 31.0 ± 8.0 dB, and Ref PTA4 = 23.7 ± 6.8 dB. Stars are included at frequencies where the BCI has statistically higher improvement than the reference device (α = 0.05).
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Figure 0003: Tone threshold improvements for BCI and reference device, including mean improvement and standard deviation. BCI PTA4 = 31.0 ± 8.0 dB, and Ref PTA4 = 23.7 ± 6.8 dB. Stars are included at frequencies where the BCI has statistically higher improvement than the reference device (α = 0.05).

Mentions: Figure 3 shows a graphic representation of the improvement of the warble tone thresholds at each tested frequency for the BCI, and for the reference device, in terms of mean improvement together with standard deviation. The BCI provided these patients with an improvement of 10–41 dB in the frequency range 250 to 8000 Hz. The corresponding improvement for the reference device was 3–31 dB. Wilcoxon signed rank test showed that the improvements were statistically significant over the unaided condition for both devices in all frequencies except at 8000 Hz. When comparing the improvements of the devices, the hypothesis (same improvement from the BCI and the reference device) could be rejected for frequencies of 750, 1500, 2000, 3000, and 4000 Hz, showing better improvement from the BCI than from the reference device. The PTA4 improvement (average over 500, 1000, 2000, and 4000 Hz) for the BCI was in average 31.0 ± 8.0 dB, while the PTA4 improvement for the reference device was 23.7 ± 6.8 dB. The PTA3 improvement (average over 500, 1000, and 2000 Hz) was 32.2 ± 8.0 dB for the BCI, and 26.9 ± 7.4 dB for the reference device.


The bone conduction implant: Clinical results of the first six patients.

Reinfeldt S, Håkansson B, Taghavi H, Fredén Jansson KJ, Eeg-Olofsson M - Int J Audiol (2015)

Tone threshold improvements for BCI and reference device, including mean improvement and standard deviation. BCI PTA4 = 31.0 ± 8.0 dB, and Ref PTA4 = 23.7 ± 6.8 dB. Stars are included at frequencies where the BCI has statistically higher improvement than the reference device (α = 0.05).
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4487578&req=5

Figure 0003: Tone threshold improvements for BCI and reference device, including mean improvement and standard deviation. BCI PTA4 = 31.0 ± 8.0 dB, and Ref PTA4 = 23.7 ± 6.8 dB. Stars are included at frequencies where the BCI has statistically higher improvement than the reference device (α = 0.05).
Mentions: Figure 3 shows a graphic representation of the improvement of the warble tone thresholds at each tested frequency for the BCI, and for the reference device, in terms of mean improvement together with standard deviation. The BCI provided these patients with an improvement of 10–41 dB in the frequency range 250 to 8000 Hz. The corresponding improvement for the reference device was 3–31 dB. Wilcoxon signed rank test showed that the improvements were statistically significant over the unaided condition for both devices in all frequencies except at 8000 Hz. When comparing the improvements of the devices, the hypothesis (same improvement from the BCI and the reference device) could be rejected for frequencies of 750, 1500, 2000, 3000, and 4000 Hz, showing better improvement from the BCI than from the reference device. The PTA4 improvement (average over 500, 1000, 2000, and 4000 Hz) for the BCI was in average 31.0 ± 8.0 dB, while the PTA4 improvement for the reference device was 23.7 ± 6.8 dB. The PTA3 improvement (average over 500, 1000, and 2000 Hz) was 32.2 ± 8.0 dB for the BCI, and 26.9 ± 7.4 dB for the reference device.

Bottom Line: The surgical procedure was found uneventful with no adverse events.All BCI results were better than, or similar to the reference device results, and the APHAB and GBI questionnaires scores showed statistically significant improvements versus the unaided situation, supporting the second and third hypotheses.The BCI provides significant hearing rehabilitation for patients with mild-to-moderate conductive or mixed hearing impairments, and can be easily and safely implanted under intact skin.

View Article: PubMed Central - PubMed

Affiliation: * Department of Signals and Systems, Chalmers University of Technology , Gothenburg , Sweden.

ABSTRACT

Objective: To investigate audiological and quality of life outcomes for a new active transcutaneous device, called the bone conduction implant (BCI), where the transducer is implanted under intact skin.

Design: A clinical study with sound field audiometry and questionnaires at six-month follow-up was conducted with a bone-anchored hearing aid on a softband as reference device.

Study sample: Six patients (age 18-67 years) with mild-to-moderate conductive or mixed hearing loss.

Results: The surgical procedure was found uneventful with no adverse events. The first hypothesis that BCI had a statistically significant improvement over the unaided condition was proven by a pure-tone-average improvement of 31.0 dB, a speech recognition threshold improvement in quiet (27.0 dB), and a speech recognition score improvement in noise (51.2 %). At speech levels, the signal-to-noise ratio threshold for BCI was - 5.5 dB. All BCI results were better than, or similar to the reference device results, and the APHAB and GBI questionnaires scores showed statistically significant improvements versus the unaided situation, supporting the second and third hypotheses.

Conclusions: The BCI provides significant hearing rehabilitation for patients with mild-to-moderate conductive or mixed hearing impairments, and can be easily and safely implanted under intact skin.

No MeSH data available.


Related in: MedlinePlus