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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

Patient audiograms with air conduction (AC) and masked bone conduction (BC) thresholds. Blue symbols = left; red symbols = right; x = left AC; o = right AC;] = left masked BC; and [= right masked BC. In patients 2 and 4, some BC thresholds were not reached due to over-masking (]] or [[). Pat = patient; R = right; and L = left.
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Figure 0002: Patient audiograms with air conduction (AC) and masked bone conduction (BC) thresholds. Blue symbols = left; red symbols = right; x = left AC; o = right AC;] = left masked BC; and [= right masked BC. In patients 2 and 4, some BC thresholds were not reached due to over-masking (]] or [[). Pat = patient; R = right; and L = left.

Mentions: Six patients have been included in the clinical study after baseline tone and speech audiometry. Audiograms for each of these patients are shown in Figure 2. The etiology of hearing loss, implant side, gender, and age at implantation are shown in Table 1. The inclusion criteria for the clinical study are as follows:


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)

Patient audiograms with air conduction (AC) and masked bone conduction (BC) thresholds. Blue symbols = left; red symbols = right; x = left AC; o = right AC;] = left masked BC; and [= right masked BC. In patients 2 and 4, some BC thresholds were not reached due to over-masking (]] or [[). Pat = patient; R = right; and L = left.
© Copyright Policy - open-access
Related In: Results  -  Collection

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

Figure 0002: Patient audiograms with air conduction (AC) and masked bone conduction (BC) thresholds. Blue symbols = left; red symbols = right; x = left AC; o = right AC;] = left masked BC; and [= right masked BC. In patients 2 and 4, some BC thresholds were not reached due to over-masking (]] or [[). Pat = patient; R = right; and L = left.
Mentions: Six patients have been included in the clinical study after baseline tone and speech audiometry. Audiograms for each of these patients are shown in Figure 2. The etiology of hearing loss, implant side, gender, and age at implantation are shown in Table 1. The inclusion criteria for the clinical study are as follows:

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